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Sn-Qc-Sapp-002 Cexime 400MG Caps.
Sn-Qc-Sapp-002 Cexime 400MG Caps.
Sn-Qc-Sapp-002 Cexime 400MG Caps.
AMENDMENT
WRITTEN BY QC OFFICER
APPROVED BY QC MANAGER
INITIATED
REV. # DATE PAGE # NATURE OF AMENDMENT DONE BY
BY
00 05.06.2007 USMAN ALL New Introduction
1
SN/QC/SAPP/002
Department Quality Control Issue # 0 3
Section Quality Control Issue Date 0 6 - 2 0 1 9
STANDARD ANALYTICAL PROCEDURE
CEFIXIME 400 MG CAPSULE
CONTENTS
AMMENDMENT 01
1.0 PURPOSE 03
2.0 SCOPE 03
3.0 PROCEDURE 03
2
SN/QC/SAPP/002
Department Quality Control Issue # 0 3
Section Quality Control Issue Date 0 6 - 2 0 1 9
STANDARD ANALYTICAL PROCEDURE
CEFIXIME 400 MG CAPSULE
1.0 PURPOSE
This document is established to define the method of analysis for in process and finished product Cexime
capsules to confirm its physical and chemical properties.
2.0 SCOPE
This procedure is applicable in the Quality Control Department for the analysis of Incoming product Cexime
capsules.
3.0 PROCEDURE
Collect the sample according to sampling procedure (sop number SN/QC/SOP/021) and analyze it according to
the standard analytical procedure.
4.0 RESPONSIBILITY:
ANALYST
MANAGER Q.C
6.0 TESTS
6.1 Instruments
a) Volumetric Flask 100 mL
b) Beakers
c) Pipette 1 mL
d) Electric Balance
e) Spectrophotometer.
6.2 Reagents/Chemicals
a) Distilled Water
b) Methanol
c) Octadecylsilanized silica gel
d) 0.05 M phosphoric acid
e) Monobasic potassium phosphate
f) Anhydrous dibasic sodium phosphate
g) Hydrochloric acid solution
h) Potassium phosphate
i) Acetonitrile
3
SN/QC/SAPP/002
Department Quality Control Issue # 0 3
Section Quality Control Issue Date 0 6 - 2 0 1 9
STANDARD ANALYTICAL PROCEDURE
CEFIXIME 400 MG CAPSULE
SAMPLE PREPARATION:
TEXT TECHNICAL
Weigh accurately 140mg powder equivalent to 100mg of 0.140gm 100mL buffer
cefixime to a 100 mL volumetric flask, dilute with buffer.
Take 1 mL and dilute to 100 mL with buffer. Measure the 1mL 100mL buffer
absorbance at about 288 nm. ʎ= 288nm
STANDARD PREPARATION:
TEXT TECHNICAL
Exactly weigh reference cefixime 112mg in 100 mL 0.12gm 100mL buffer
volumetric flask, dilute with buffer. Take 1 mL and dilute to
100 mL with buffer. Measure the absorbance at about 288 1mL 100mL buffer
nm. ʎ= 288nm
LIMIT: 90 –105%
6.3.3 ASSAY FOR CAPSULES:
BUFFER PREPARATION:
Potassium dihydrogen phosphate 6.85g and sodium hydroxide pellets 0.92g in 1000mL water.
SAMPLE PREPARATION:
TEXT TECHNICAL
Empty 20 Capsules, Weigh accurately 140mg powder 0.140gm 100mL buffer
equivalent to 100mg of cefixime to a 100 mL volumetric
flask, dilute with buffer. Take 1 mL and dilute to 100 mL 1mL 100mL buffer
with buffer. Measure the absorbance at about 288 nm. ʎ=288nm
STANDARD PREPARATION:
TEXT TECHNICAL
Exactly weigh reference cefixime 112mg in 100 mL 0.12gm 100mL buffer
volumetric flask, dilute with buffer. Take 1 mL and dilute to
100 mL with buffer. Measure the absorbance at about 288 1mL 100mL buffer
nm. ʎ=288nm
LIMIT: 90 –105%
4
SN/QC/SAPP/002
Department Quality Control Issue # 0 3
Section Quality Control Issue Date 0 6 - 2 0 1 9
STANDARD ANALYTICAL PROCEDURE
CEFIXIME 400 MG CAPSULE
6.3.4 (HPLC METHOD)
Sample preparation:
TEXT TECHNICAL
Take out the contents of NLT 20 cefixime capsules, weigh 0.1 g 100mL (0.1mol/L phosphate)
accurately the mass of the contents and powder. Weigh
accurately a portion of powder, equivalent to about 0.1g of 10mL 50mL (0.1mol/L phosphate)
Cefixime hydrate add 70mL of 0.1 mol/L phosphate buffer
solution (pH 7.0) and shake for 30 min, add 0.1 mol/L
phosphate. Buffer solution to make exactly 100mL.
Centrifuge this solution, pipette 10 mL of supernatant
liquid, add 0.1mol/L phosphate buffer solution to make
exactly 50mL and use this solution as Sample solution.
Standard solution:
TEXT TECHNICAL
Separately, weigh accurately an amount of cefixime RS 20mg 100mL (0.1mol/L phosphate)
equivalent to about 20mg dissolve in 0.1 mol/L Phosphate
buffer solution to make exactly 100mL, and use this
solution as standard solution.
6.3.5 DISSOLUTION:
Standard solution:
TEXT TECHNICAL
Dissolve 0.0559g of Cexime in 50 mL of phosphate buffer, 0.0559 g 50mL
and dilute 1mL in phosphate buffer and make up volume 1mL 50mL
upto 50mL. ʎ = 228 nm
Sample solution:
TEXT TECHNICAL
Add one capsule in each basket, volume of 900mL 0.05M 1 capsule 900mL phosphate buffer
phosphate buffer, dissolve 400mg of Cexime (one capsule) 5mL 100 mL
in 900 mL of phosphate buffer, and take sample of 5mL Filter (0.45µm)
and make up volume upto 100mL. Filter through 0.45-µm ʎ= 228nm
filter.
5
SN/QC/SAPP/002
Department Quality Control Issue # 0 3
Section Quality Control Issue Date 0 6 - 2 0 1 9
STANDARD ANALYTICAL PROCEDURE
CEFIXIME 400 MG CAPSULE
7.0 DOCUMENTATION:
8.0 REFRENCE: