PHARMACEUTICAL

ANALYSIS
INTRODUCTION
DEFINITION
• It is defined as the application of analytical procedures used to determine the
purity, safety and quality
PURITY

Drugs
and
chemicals
QUALITY SAFETY

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PHARMACEUTICAL ANALYSIS

• APL(active pharmaceutical • Identification

ingrediant) • Solubility
• Excipients • Assay
• Formulation
• Impurities
• Biologicals

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STEPS IN ANALYSIS
• The two important steps in analysis,
• Qualitative analysis
• Quantitative analysis
• Qualitative analysis:
– It involves in the identification of any drug substance or chemicals present
in the sample or in mixture.
• Quantitative analysis:
– It is the determination of the quantitative contents of individual elements or
compounds present in a substance

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IMPORTANCE OF ANALYSIS
 Identify the drug in the formulated product.

 Determination of active ingredient or additional impurities.

 Stability of the drug.

 Rate of drug from its formulation.

 Identify and purity of drug that meet specification.

 Concentration of specified impurities.

 Concentration of drug in plasma or biological fluids.

 Determination of pKa values, partition coefficient, solubility and stability of

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drugs under development
SCOPE OF ANALYSIS
• In pharmaceutical industry- There are different sectors in pharmaceutical
industry as research and development (R&D) and Quality control (QC) in
which pharmaceutical analysis is utilises regularly
• In Food industry- As we all know packed food which consumed by consumer
should have all parameters like quality, purity and safety which enhance
acceptability by consumer. For this it is require to analyse all these parameters
for packed food.
• In Cosmetic Industry- Preparation of cosmetics, as lipsticks, creams, nail-
paints, lotions, shampoo and conditioners etc., play with two things as colour
and odour and these colouring agents and fragrances are also build by different
chemical ingredients so the quality and quantity of these ingredients should be
known which can be analyse by different techniques of analysis.
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CONTD…

• In Environmental study- Pharmaceutical analysis have different techniques

which can be applicable in environmental studies as to check pH of rain, river
and water resources.
Different environmental factors like temperature, humidity etc can be
analyse by analytical method.
Various organic and inorganic compounds and elements in soil can also
be analysed by analysis techniques.
• 5. In Disease diagnosis- Different diseases can be diagnosed by
pharmaceutical analysis techniques like HIV is observed by ELISA method.

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DIFFERENT TECHNIQUES OF ANALYSIS
• There are different techniques available to analyse drugs and chemicals to be
estimated quantitatively to the analytical chemist.
• The techniques have differing degrees of saponification, of sensitivity, of
selectivity (3S)
• It can be classified depending upon the method of analysis and by using
instrument or non- instruments
– Non instrumental method of analysis
– Instrumental method of analysis

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NON INSTRUMENTAL METHOD

I. TITRIMETRIC ANALYSIS (OR) VOLUMETRIC ANALYSIS

II. GRAVIMETRIC ANALYSIS
III. GASOMETRIC ANALYSIS

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TITRIMETRIC ANALYSIS
I.ACID BASE TITRATION(NEUTRALIZATION TITRATION)
Acidimetry
Alkalimetry
Non aqueous acid base titration
II. REDOX TITRATION (OXIDATION-REDUCTION TITRATION)
Permanganimetry
ceriometry
Iodometry
Iodimetry
Bromometry
Titanometry SASIKALA ,MPHARM, NCP 10
CONTD..
III. PRECIPITATION TITRATION
Mohrs methos
Volhards method
Fajans method
Gay – lussac method
IV. COMPLEXOMETRIC TITRATION
Direct titration
Back titration
Replacement or substitution titration
Alkalimetric titration of metals
Indirect titration
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CONTD..

V. MISCELLANEOUS METHOD
Diazotization titration
Kjeldahl method of nitrogen estimation
Oxygen flask combustion
Karl – fischer titration

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INSTRUMENTAL METHOD OF ANALYSIS
I.OPTICAL METHOD OF ANALYSIS
 Colorimetry
 UV spectrophotometry
 IR spectrophotometry
 Atomic absorption spectroscopy
 Nephlometry and turbidometry
 Refractometry
II. ELECTRICAL METHOD OF ANALYSIS
• Potentiometry
• Conductometry
• Voltametry
• Coulometry
• polarography
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CONTD..
III. EMISSION METHOD
 Emission spectroscopy
 Fluorimetry
 Flame photometry
IV. OTHER TECHNIQUES
 X- ray spectroscopy
 Mass spectroscopy

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FUNDAMENTALS OF TITRIMETRIC ANALYSIS
• TITRATION
It is the process in which the standard solution is added in a controlled
manner from the burette to the sample to be estimated until the reaction is just
complete
• TITRATE (OR) ANALYTE
The substance to be analysed
• TITRANT
The reagent of known concentration which is added in a controlled
manner to the solution of the substance which is estimated .
• EQUIVALENT WEIGHT
It depend upon the type of reaction involved in a titration
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CONTD..
• INDICATORS;
It defined as the compounds which shows well marked colour changes at
completion of the chemical reaction.
• END POINT:
It otherwise called equivalence point or stoichiometric point.
It defined as at which a complete chemical reaction take place.

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