Anupama Final

Analysis of active pharmaceutical ingredient bupropion Hydrochloride drug by HPLC and
GC method.
INTRODUCTION
A drug is a chemical used medicinally for treating diseases and injuries. Many drugs or
medicines are entirely legal, readily available and are sold as over the counter medications
without the need for a prescription. Over the counter drug include categories of drugs such as
pain relievers, Antacid, Alcohols, Caffeine, and Vitamins. Dosage information and
precaution are strictly followed in order to prevent accidental injury or harm.
Bupropion hydrochloride is a unicyclic, aminoketone antidepressant the mechanisam of its
therapeutic action is not well understood, but it does appear to block dopamine uptake the
hydrochloride is available as on aid to smoking cessation treatment.
Chromatography is a technique widely used to separate the mixture of compounds into its
individual form and obtain pure compounds from the mixture.
Principle:- chromatography is based on the principle of separation of compounds into
different bands and the identification of those bands. The preferential separation is done due
to different affinities of compounds towards stationary and mobile phase.
Components:-
 Stationary phase:- The stationary phase is one which stays motionless and allow
sample to move over it.
 Mobile phase:- This is the chromatographic liquid phase and it helps the sample
move over the stationary phase.
Types of chromatography:-
1. Thin layer chromatography
2. Paper chromatography
3. Column chromatography
4. Ion exchange chromatography
5. Gas chromatography
6. High performance liquid chromatography
High performance liquid chromatography is a technique in analytical chemistry used to

separate, identify and quantify each component in a mixture.
Gas chromatography refers to a physical process by which a mixture is separated into its
constituents by moving gas phase passing over a stationary sorbent.
Karl-Fischer Titration is classic titration method in analytical chemistry that was colorimetric
or volumetric titration to determine amount of water in a sample.
Department of Chemistry. Government Science College Chitradurga. Page 1

GC method.
LITERATURE SURVEY
Literature survey on chromatographic technique reveals that they are highly useful and
effective analytical methods for the analysis of drugs quantitatively as well as qualitatively.
These methods are especially revealed by the famous
 Journal of chromatography A. 1036, Gerber, F; Krummen, M; Potgeter, H; Roth, A;
Siffrin, C ; Spoendlin, C2: 127-133 (2004).
 Journal of chemical education , 74 : 45 by Karger, Barry L. (1997).
These technique of separation and identification of newly synthesized drugs
promoted us to take up this project

GC method.
OBJECTIVES
The main objective of this project is to study the parameters of drugs composition and
to get satisfactory result and to make the method to be rapid, simple, accurate, linear,
selective, economical, and reproducible and to have short run time and to achieve low cost
technology which makes this method economically alternative for most clinical laboratories.
PLAN OF THE WORK
Analysis of chemicals by chromatographic method is one of the important and
accurate methods of all the techniques. So this has attracted much interest due to their wide
range of usefulness. In the last few years the method is developed as a new challenge to
chemical and pharmaceutical industries for the analysis of different chemicals and drugs. In
addition the study and development of technology by chromatography could be helpful in the
design and development of new methods in finding the new parameters.
The main aim of this project is to study the parameters of drug components to attain its
effective function.

GC method.
INTRODUCTION TO BUPROPION HYDROCHLORIDE

BUPROPION HYDROCHLORIDE was synthesized in 1966 by
Burroughs research group of scientists “an agent that would be active in
antidepressant screening model, but differ chemically and pharmacologically from
the tricyclics & not be sympathomimetic, cholinolytic nor an inhibitor of
monoamine oxidase
Bupropion hydrochloride is a unicyclic, aminoketone antidepressant the mechanism

of its therapeutic action is not well understood, but it does appear to block dopamine
uptake the hydrochloride is available as on aid to smokingcessation treatment.
Bupropion hydrochloride contains not less than 98% & not more than 102% of C13
H18 CION HCL. or C13H19CL2NO. It is used to treat major depressive disorder &
seasonal affective disorder. The Zyban brand of bupropion is used to help people
stop smoking by reducing craving & other withdrawl effects .
Pharmaceutical information of the drug:-

1. Drug Substance :-
Proper name :- Bupropion hydrochloride.
Molecular formula :- C13H18CINO HCL. or C13H19CL2NO.
Structural formula :-
Molecular weight :- 276∙ 202g/mol.

Solubility :- soluble in water & ethanol , methanol.
Melting point :- 233⁰c - 234⁰c.
Boiling point :- 334∙8⁰c.
Storage:- 15- 20⁰c at room temperature.
IUPAC NAME :- 2−( tert-butylamino)-1-(3-chlorophenyl) propan-1-one;hydrochioride.

GC method.
2. Medical uses of Bupropion hydrochloride:-

1. BPR is used as an antidepressant and smoking cessation aid.
2. It is also used to prevent seasonal affective disorder.
3. It is also used to treat attention deficit hyperactivity disorder (ADHD).
4. It may also be used along with mood stabilizes to treat bipolar disorders.
3. Side effects:-
 Dry mouth,
 Increasing sweating or shaking,
 Trouble sleeping ,
 Decreasing appetite,
 Headache and Increased urination.

GC method.
DATA ANALYSIS OF BUPROPION HYDROCHLORIDE BY HIGH

PERFORMANCE LIQUID CHROMATOGRAPHY METHOD:-
Introduction
High performance liquid chromatography is a technique in analytical chemistry used to

separate , identify each component in a mixture. It is an effective type of column
chromatography which is widely used in pharmaceuticals it is very useful to determine the
assay and related substance in drug. In general HPLC is used to separate the components of a
mixed drug substances.
In HPLC column plays a significant role in separation of different compounds because it

contains stationary phase. Stationary phase is a bed of polar and non-polar particles according
to type of column. Polar and non-polar compounds are used according to the nature of the
sample to be analyzed.
PRINCIPLE
In HPLC, eluent from the solvent reservoir is filtered pressurized and pumped through the
column. A mixture of solutes injected at the top of the column is separated into components.
Individual solutes are monitored by the detector and recorded automatically.
Types of HPLC based on mode of separation:-
 Normal phase chromatography:-

The stationary bed is strongly polar in nature (eg:silica gel) and the mobile phase is non
polar (such as n-hexane or Tetrahydrofuran). Polar substances are thus retained on the polar
surface of the column packing longer than less polar materials.
 Reversed phase chromatography:-

The stationary bed is non polar(hydrophobic) in nature, while the mobile phase is a polar
liquid, such as mixtures of water and methanol or Acetonitrile. Here the more non polar the
material is longer it will be retained.

GC method.
Characteristics feature of HPLC
 High resolving power and speedy separation.

 Accurate quantitative measurements.
 Continuous monitoring of column effluent.
 It can determine multiple component in a single analysis.
 Separated components can be easily collected from the mobile phase for further
characterization.
 Rapid technique applicable to all kinds of chromatgraphic methods such as
absorption, ion exchange, partition and exclusion chromatography.
 A variety of solvents sample recovery is easy.
 Analyses are completed it in few minutes with excellent Precision and accuracy.
 HPLC provided with automatic analytical procedure and data handling
 Repetitive and reproducible analysis using the same column
 Chromatography separation in HPLC is the result of specific interaction between the
sample molecules with both the stationary phase and mobile phase.
INSTRUMENTATION

GC method.
Schematic representation of HPLC:-
A typical modern liquid chromatography consist of following components
 Solvent delivary system

 Sample injection system
 Column
 Detector
 Recorded
 Data control and display
Solvent delivary system
The pump is one of the most important components of HPLC, since its performance
directly affects retention time, reproducibility and detector sensitivity. The pump delivers a
steady steam of solvent from the reservoir to detector through the column. The Pump can
psi with flow rate over 50 cm3 per minute. Most of
deliver solvent at a pressure up to 10000 ps
the separations done by HPLC require pressure between 400 and 1500 psi.
Types of pumps
 Gas displacement pumps

 Pneumatic pump
 Syringe pump
 Reciprocating pump
Department of Chemistry.
hemistry. Government Science College Chitradurga. Page 8
GC method.
 Sample injection system

Sample injection system consisting of two types of injecting system
 Syringe injection
 Stop-flow injection
HPLC VIALS
 Column
Columns are considered as the ”HEART OF CHROMATOGRAPHY”. The column is

made from precision bore polished stainless steel tubing , typical dimensions being 10
cm-30cm long and 4mm-5mm in internal diameter. Temperature of the column affects
speed of affinity, viscosity of the solvent, diffusion and solubility of the sample. Columns
are thus used in thermostatic ovens.
 Detector:-
In HPLC , the function of detector is to monitor the mobile phase as it emerges from
the column.

GC method.
Characteristic of a detector
 Sensitivity
 Linear response
 Type of response
Types of detector
 Ultraviolet detector
 Photodiode array detector
 Ultraviolet detector
The UV absorption detectors have been used widely in HPLC. It is on the principle
of absorption of UV visible light as the effluent from the column is passed through a
flow cell held in radiation beam.
 Photodiode array detector:-

Can be recorded whole of the spectrum many times a second. In these detector,
polychromatic light is passed through the HPLC flow cell and the emerging radiation
is diffracted by a grating to fall on the array.
 Recorder
The signal from the detector is recorded as deviation from a base line. Two open
recorders are used with instruments having two detectors. The peak position along the
curve relative to the starting point, denotes the particular components with proper
calibration , the height or area of peak is a measure of the amount of the component
present in the sample.

GC method.
Uses of HPLC:-
This technique is used,
 In chemistry and biochemistry research analysing the complex mixtures.
 Purifying the chemical compounds.
 Developing processes from synthesizing chemical compounds.
 Isolating natural products and predicting the physical properties.
 It is also used in a quality control to ensure the purity of raw materials.
 To control and improve process yield.
 To quantity assays of final products.
 To evaluate products stability and monitor degradation.

GC method.
DATA ANALYSIS OF BUPROPION

HYDROCHLORIDE BY HPLC:-
Preparation of 0∙0025M phosphate buffer:-
Transfer accurately about 6⋅8g of potassium dihydrogen orthophosphate into a bottle Add
2000 ml of purified water dissolve and mix well. Adjust the PH to 7⋅0 ± 0⋅05 using 1N
Sodium hydroxide.
Preparation of mobile phase :-
Mix 0⋅025 M Phosphate buffer , HPLC grade methanol and HPLC grade tetra hydro furan in
the ratio 51∶ 39∶11 filter through 0⋅45 μ membrane and degas with sonication for 5 minutes .
Diluent:-
50 Use a degased mixture of purified water and methanol in the Χ
Preparation of system suitability solution:-
Transfer accurately about 2⋅5 mg of USP Bupropion hydrochloride related compound- A and
USP Bupropion hydrochloride related compound –B standards into 100 ml volumetric flask
dissolve and dilute to volume with diluents and label it as system suitability solution .
Standard preparation:-
Transfer accurately about 2⋅5 mg of USP Bupropion hydrochloride standard into 25 ml

volumetric flask , dissolve in portion of diluent. Add 2⋅0 ml of system suitability solution
into the same flask , dilute to volume with diluent.
Sample preparation:-
Transfer accurately about 50 g of Bupropion hydrochloride sample into 50 ml volumetric
flask, dissolve and dilute to volume with diluent.

GC method.
Chromatographic conditions:-
Column Insert C8 −3, 150Χ 3⋅9mm, or

equivalent.
30⁰c .
Column temperature
1⋅1 ml/ min.

Flow rate
250nm.
Detector wavelength
20μ L.
Injection volume
60 minutes.
Run time
About 15 minutes.
Retention time

GC method.
GRAPHS
Spectrum of HPLC Blank
Spectrum of HPLC Samples

GC method.
Spectrum of HPLC Standard

GC method.
DATA ANALYSIS OF BUPROPION HYDROCHLORIDE BY GAS

CHROMATOGRAPHY
INTRODUCTION
 Modern gas chromatography (GC) was invented by MARTIN and JAMES IN

1952 and has become one of the most important and widely applied analytical
techniques in modern che
chemistry.
 GRIFFIN and GEORGE probably manufactured the first commercial GC system
in 1954.
Instrumentation of GC
Schematic representation of GC
Department of Chemistry.
hemistry. Government Science College Chitradurga. Page 16
GC method.
High pressure cylinder containing a carrier gas
 Sample injection system

 Column
 Thermal compartment and the
 Detector
 Supply of carrier gas from high pressure cylinder

The carrier gas is either H2 , He ,CO2 or Ar the choice depends on factors such as
nature of sample , purity, availability, consumption , column efficiency and the type of
detector employed. Thus helium is preferred when thermal conductivity detector are
employed because of its high thermal conductivity relative to the vapours of most
organic compounds. Flow rate greatly influence column efficiency.
 Injection system used in capillary GC

 Split injection method
 Split less injection system
 Direct on column method
 Automatic sampler
 Headspace sampling
Split injector:-

GC method.
 Column
The actual separation of sample component are effected in the column. The
nature of the solid support, the type and amount of liquid phase, the method of
packing ,length and temperature are important factors in obtaining the desired
resolution. The Column is enclosed in thermostatically controlled oven so that its
temperature is held constant, ensuring reproducible conditions. The operating
temperature may range from ambient over 673 K.
Types of column
 Packed column
 Capillary column
There are two types of columns: OPEN TUBULAR COLUMN and PACKED COLUMN
 Open tubular columns are also known as capillary columns

 Packed columns are made of glass or metal tubing which is densely packed
with a solid support like diatomaceous earth.
 Thermal compartments
The column is operated thermally if a sample contains several compounds having a
wide range of boiling points. Now linear and non- linear temperature of the column
can be maintained uniform about the 273.1 k by the use of vapour jacket or liquid
baths.
 Detector
A detector located at the exit of the separation column senses the presence of small
amounts of individual components as they leave the column.
The choice of detector depends on factor such as the concentration level to be

measured and the nature of the separated components.

GC method.
Types of detector
Ionization detector
Carrier gases behave as perfect insulator at normal temperature and pressure. The
increased conductivity due to charge ions in the effluent from the column provides high
sensitivity which is a feature of ionization based detector. Thus ID operates by measuring the
electrical conductivity of a gas which is directly proportional to the concentration of the
charged particles within the gas . Current ionization detector thermionic ionization detector ,
photo ionization detector and electron capture detector.
Flame ionization detector
The basis of FID is that the effluent from the column is mixed with H2 and burned in air to
produce a flame which ionizes the solute molecules having ionization potential. The burner
jet is the negative electrode while the anode is usually a wire extending into the tip of the
flame. When ionizable material from the column effluent enters the flame and is burned, the
current markedly increases. The current flows through an external resistor is sensed as a
voltage drop, amplified and finally sent to an output device, a recorder.
Schematic diagram of a flame ionization detector

GC method.
Applications of Gas chromatography

 Gas chromatography is used in many different fields such as pharmaceuticals
cosmetics and Evan environmental toxins.
 Air samples can be analysed using gas chromatography. Most of the time air quality
control units used gas chromatography coupled with flame ionization detector in order
to determine the components of a given air sample.
 Gas chromatography is another useful method which can determine the components
of a given mixture using the retention time and the abundance of the samples.
 The precission the accuracy of the method is very high.
 The technique has strong separation power and even Complex mixtures can be
resolved into constituents.
 In industry:
 Ultrasensitive detector in GC are useful in the field of food products.
 Fatty acids, steroids, high boiling and thermally unstable materials have been
separated after converting them into the volatile and thermally stable
derivatives such as esters, acetates or trifluroacetates.
 A large number of industrial products including herbicides, pesticides,
fertilizers, pharmaceuticals, cosmetics, perfumes, protective coatings, plastic
materials, alcoholic beverages, rubber and rubber products , soap and synthetic
detergents have been analysed and separated by gas chromatography. The
technique is used in determination of water in butane gas , creams, emulsion ,
ointments and pastes etc. crude petroleum products gasoline, hydrocarbons, N
and S compounds have been separated by GC and identified by IR , NMR ,
UV and MS techniques.
 In Elemental analysis:
 In determination of C, H and N.
 In determination of Sulphur.
 In determination of total organic carbon.

GC method.
DATA ANALYSIS OF BUPROPION HYDROCHLORIDE BY

GC:-
Blank preparation:-
Transfer 1⋅0ml of dimethly formamide into a vial and seal with the septum and Aluminium
Cap using crimper.
Standard stock solution:-

Weigh accurately about 100mg of Di-isopropylether, 500mg of Isoproply alcohol, 89 mg of
Toluene and 60 mg of Dichloromethane into 100 ml Volumetric flask containing about 20 ml
of dimethly formamide and make upto the mark with dimethyl formamide. Dilute 5⋅0ml of
this solution to 50⋅0 ml in 50ml Volumetric flask with Dimethly formamide.
Standard solution:-
Transfer 1⋅0 ml of each standard stock solution separately into required number of headspace
vials and seals with the septum and aluminium cap using crimper.
Test solution:-
Transfer accurately about 100 mg of sample and 1⋅0 ml of dimethly formamide into two vials
separately, sonicate to dissolve and seal the vials with the septum and aluminium cap using
crimper.

GC method.
GC Conditions:-
Column ELITE−624, 30m length and

0⋅25mm ID, Film thickness,
1⋅4μm (part #N93 16201, SI #
688420) or equivalent.
Column Detector Flame ionization detector.
Oven temperature program Initial 70⁰c, hold for

4−minutes , increase @ 40⁰c
per minute to 180⁰c hold for 4
minutes.
Detector temperature 200⁰c.
Injector temperature 190⁰c.
Carrier gas Nitrogen.
Split ratio 1∶1
Detector range 1
60Kpa.
Carrier gas flow
Isopropyl alcohol, about 4∙5
Retention time
minutes.
Head space conditions:-
90⁰c
Oven temperature
100⁰c
Needle temperature
110⁰c
Transfer line temperature
15 mins
Thermostat time
30 mins
Pressurisation time
0∙05 mins
Injection time
0∙5 mins
Withdrawl time

GC method.
GC ANALYSIS:-
 Condition the column at 200⁰c for one hour.
 Allow the gas chromatograph to equilibrate at 70⁰c . until a steady baseline
is obtained.
 After the system has equilibrated make one injection of blank preparation.
 Make one injection each from six standard vials ensure that system
suitability parameter meets the specified criteria.
 Make one injection of each sample preparation.
 Make one injection of standard preparation at end of the sequence or after
every 5th batch.
Spectrum of GC Blank

GC method.
Spectrum of GC Standard
Spectrum of GC Sample

GC method.
Calculation and Results:-

Calculate the solvent content in the individual sample preparation using the
following formula and report the average results.
Concentration in PPM = 10
Where, At is the area of solvents peak in test standard sample solution.
As is the mean area of respective solvent peak in six standard solutions.
Ws is the weight of respective solvents reference / working standard in mg.
Wt is the weight of the sample is mg.
Spectrum of GC Standard:- Calculation of IPA
Concentration in PPM = 10
= 4756 Χ 500 Χ 5 Χ 1 Χ 106 = 62.036775 PPM

383321 Χ 100 Χ 50 Χ 100
Calculation of DCM
Concentration in PPM = 1027 Χ 60 Χ 5 Χ 1 Χ 106 = 17.1290376 PPM
35974 Χ 100 Χ 50 Χ 100

GC method.
DETERMINATION OF MOISTURE CONTENT IN SAMPLE
Karl-Fischer Titration
Karl-Fischer Titration is a classic titration method in analytical chemistry that was
colorimetric or volumetric titration to determine amount of water in sample. It was invented
in 1935 by German chemist Karl Fischer.
INSTRUMENT
Apparatus:-
 Karl-fisher titrator
 Analytical balance Sensitivity 0.1g
 Closed glass weighing spoon.

GC method.
Scope
This method may be used for any kind of dried milk products especially those containing
crystallized lactose.
PRINCIPLE
The determination of total moisture by Karl Fischer titration is a calculation based on the
concentration of iodine in the karl-fisher titrating reagent consumed in the titration. The end
point of the titration is determined by dead stop end point method.
Reagents
 Karl Fischer reagent

 Methanol and purified water
PROCEDURE
Transfer about 25 ml of methanol into Karl Fischer titrate vessel and titrate with Karl
Fischer reagent to neutralize determine the end point potentiometrically. Weigh accurately
about 2 g of sample, transfer into the Karl Fischer titration vessel. Titrate with Karl Fischer
reagent. Calculate the strength of Karl Fischer reagent as water equivalence (mg/ ml) using
the formula.
ℎ × 100
=
Determination of water in sample

Weigh accurately quantity of material specified in relevant method of analysis and
transfer into a titration vessel containing previously titrated methanol with Karl Fischer
reagent.
Titrate with Karl Fischer reagent and determine the end point potentiometrically in duplicate
and note down the volume of Karl Fischer reagent consumed.
× × 100
(%) =
1000 × ℎ

GC method.
Finally calculate the amount of water in the sample by using the following
formula.
. . .
Water Content (%) =
. . .
=
.
0.0389 ≅ 0.04%

GC method.
RESULT AND DISCUSSION:-
The following table consists of test performed on the sample Bupropion

Hydrochloride along their results and specifications
Tests Specifications. Results.

SI.NO
A White crystalline powder White
1. Description
powder.
2.
Identification
1) By GC
Not more than 600ppm.
DCM
Not more than 1000ppm.
. DIPE Complies
Not more than 5000ppm. .
. IPA
Toluene Not more than 890ppm.
2) By The retention time of the

HPL major peak in the
C chromatogram of the assay
preparation should Complies
correspond to that in .
chromatogram of the
standard preparation.
Meets the
3. Solubility Soluble in water , in 0∙1N
requirem
HCL AND Alcohol.
ents.
Melting point 233⁰c− 234⁰c . 233.2⁰c
4.
Water content Not more than 1∙0% w/w. 0∙03%
5.
by K.F.
Residue on Not more than 0∙1% w/w . 0∙1%
6.
ignition

GC method.
CONCLUSION:-
Different set of analysis method is being developed for the analysis of bio-chemical
compounds such as drugs;Bupropion hydochloride is one which plays an important role in
analysis process.Material and active pharmaceutical ingredients are tested before they are
used for the manufacturing in large scale and based on their results obtained products are
passed with the analytical development lab (ADL) . statistical analysis of the results shoes
the proposed procedure has good precision and accuracy and it shows satisfactory results for
all the method validation parameters tested.

GC method.
REFERENCE:-
 “Zyban 150mg prolonged release film —coated tablets-summary of product

characteristics (SPC)”. Electronic Medicines compendium. GlaxoSmithKline UK.
 “Prexaton Bupropion hydrochloride PRODUCT TNFORMATION”. TGA
business services. Ascent pharma pvt Ltd.
 Zhu, A.Z.X.,Zhou, Q,Cox,L.S.; Ahluwalia, J.S. Benowitz, N.L; Tyndale, R.F.
“Gene Variants in CYP2C19 Are Associated with altered in vivo Bupropion
pharmokinetics but not Bupropion-Assisted Smoking Cessation Outcomes”. Drug
Metabolism and Disposition.
 Brunton, L, chabner, b, Knoliman, B. Goodman and Gilman’s The Pharmological
basis of therapeutics. New York; McGraw-Hill professional.
 Morton ,lan, morton, I.K, Hall, Judith M. Concise Dictionary of Pharmalogical
Agents; Properties and Synonyms. Springer science and business media.
 Dictionary of Organic compounds. CRC Press.pp. 104.
 Index Nominum 2000: International Drug Dictionary. Taylor and Francis.january
2000.
 “Bupropion (by mouth)”. Pub med Health. Bethesda, USA: National Institution of
Health.
 Brayfield, A.ed. “Bupropion”. Martindale: The Complete drug reference. London,
UK: Pharmaceutical Press.
 Dwoskin, Linda P. Emerging Targets and Therapeutics in the Treatment of
psychostimulant Abuse. Elsevier science.
 Tasman, Allan,Kay, Jerald, Lieberman, Jeffrey A, First, Michael B, Maj, Mario.
Psychiatry. John wiley & sons.
 Lemke, Thomas L., Willams, David A. Foye’s principles of medicinal chemistry.
Lippinott Williams & Wikkins.
 The INN originally assigned in 1974 by the World HealthOrganisation was
“amfebutamone”. In 2000, the INN was reassigned as Bupropion. See World
Health Organisation (2000). “International Non-proprietary Names of
Pharmaceuticals Substances (INN): Proposed INN: List 83”
 Moreira R. The efficacy and tolerability of bupropion in the treatment of major
depressive disorder”.
GC method.
 Cipriani A, Furukawa TA, Salanti G, Geddes JR, Higgins JP, Churchill R,

Watanabe N, Nakagawa A, Omori TM, McGuire H, Tanselaa M, Barbui C.
“Comparative efficacy and acceptability of 12 new-generations antidepressants: a
multiple- treatments meta analysis”.
 Clayton AH (2003). “Antidepressant-Associated Sexual Dysfunction:A
Potentially Avoidable Therapeutic Challenge”
 Baldwin Ds, Papakostas GI (2006). “Symptoms of fatigue and sleepiness in major
depressive disorder”. J Clin Psychiatry. 67 suppi 6.
 Zisook S, Rush AJ, Haight BR, Clines DC, Rockett CB. “Use of Bupropion in
combination with serotonin reuptake inhibitors”. Biol. Psychiatry. “First drug for
seasonal depression”. FDA consum.
 Rossi, S, ed (2013). Australian Medicines Handbook. Adelaide: The Australian
Medicines Handbook Unit Trust.
 Joint Formulary Committee (2015). British National Formulary (BNF). London,
UK: Pharmaceutical press.
 Wilkes, S (2008). “The use of bupropion SR in cigarette smoking cessation”.
International Journal of chronic obstructive pulmonary disease.
 Hughes, JR; Stead, LF; Hartman-Boyce, J; Cahill, K; Lancaster, T.
“Antidepressants for smoking cessation”. The Cochrane database of systematic
reviews.
 Cantwell DP. “ADHD through the life span; the role of bupropion in treatment”.
 “Contrave label”. United States food and drug administration.

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Analysis of active pharmaceutical ingredient bupropion Hydrochloride drug by HPLC and

High performance liquid chromatography is a technique in analytical chemistry used to

Department of Chemistry. Government Science College Chitradurga. Page 1

These methods are especially revealed by the famous

 Journal of chromatography A. 1036, Gerber, F; Krummen, M; Potgeter, H; Roth, A;

Siffrin, C ; Spoendlin, C2: 127-133 (2004).

 Journal of chemical education , 74 : 45 by Karger, Barry L. (1997).

These technique of separation and identification of newly synthesized drugs

promoted us to take up this project

Department of Chemistry. Government Science College Chitradurga. Page 2

PLAN OF THE WORK

Analysis of chemicals by chromatographic method is one of the important and

design and development of new methods in finding the new parameters.

Department of Chemistry. Government Science College Chitradurga. Page 3

INTRODUCTION TO BUPROPION HYDROCHLORIDE

Bupropion hydrochloride is a unicyclic, aminoketone antidepressant the mechanism

Pharmaceutical information of the drug:-

Molecular formula :- C13H18CINO HCL. or C13H19CL2NO.

Molecular weight :- 276∙ 202g/mol.

Department of Chemistry. Government Science College Chitradurga. Page 4

2. Medical uses of Bupropion hydrochloride:-

2. It is also used to prevent seasonal affective disorder.

3. It is also used to treat attention deficit hyperactivity disorder (ADHD).

 Increasing sweating or shaking,

 Headache and Increased urination.

Department of Chemistry. Government Science College Chitradurga. Page 5

DATA ANALYSIS OF BUPROPION HYDROCHLORIDE BY HIGH

High performance liquid chromatography is a technique in analytical chemistry used to

In HPLC column plays a significant role in separation of different compounds because it

Types of HPLC based on mode of separation:-

 Normal phase chromatography:-

 Reversed phase chromatography:-

Department of Chemistry. Government Science College Chitradurga. Page 6

Characteristics feature of HPLC

 High resolving power and speedy separation.

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Schematic representation of HPLC:-

A typical modern liquid chromatography consist of following components

 Solvent delivary system

Solvent delivary system

 Gas displacement pumps

 Sample injection system

Columns are considered as the ”HEART OF CHROMATOGRAPHY”. The column is

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 Photodiode array detector:-

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This technique is used,

 In chemistry and biochemistry research analysing the complex mixtures.

 Purifying the chemical compounds.

 Developing processes from synthesizing chemical compounds.

 Isolating natural products and predicting the physical properties.

 It is also used in a quality control to ensure the purity of raw materials.

 To control and improve process yield.

 To quantity assays of final products.

 To evaluate products stability and monitor degradation.

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DATA ANALYSIS OF BUPROPION

Preparation of 0∙0025M phosphate buffer:-

Preparation of mobile phase :-

Preparation of system suitability solution:-

Transfer accurately about 2⋅5 mg of USP Bupropion hydrochloride standard into 25 ml

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Column Insert C8 −3, 150Χ 3⋅9mm, or

1⋅1 ml/ min.