Albendazole (Finished product) Assay (By HPLC)
Chromatographic Condition
Principle - HPLC with UV detector
Column - C18 (
150 x 3.9 mm) 5µ or equivalent
Detection - UV 235 nm
Flow rate - 2.0 ml/min.
Injection volume -20 µl
Run Time - 6 Minutes
Retention Time - About 3 Minutes
Diluent - 990 ml methanol + 10 ml Concentrated HCL
Mobile Phase - Buffer : Methanol ( 400 : 600 )
Buffer Preparation - Dissolve 7.35 gm of Disodium phosphate dodecahydtrate (Na2HPO4,12 H2O, Sodium phosphate dibasic) in 400 ml of water (If pH of the mobile phase is greater than 8.0, then adjust to 7.5 with dilute phosphoric acid)
Standard Preparation
Weigh
accurately about 50 mg Albendazole WS in a 100 ml volumetric flask. Dissolve in
diluent and dilute to 100 ml with diluent. Take 1 ml of the above and dilute to
20 ml with mobile phase.
Sample Preparation
Weigh accurately a
quantity of the powder equivalent to about 50 mg of Albendazole in 100 ml
volumetric flask add diluent upto mark and keep stirring for 30 minutes then sonicate
for 10 min. Then shake and filter. Take 1 ml of the filtrate and dilute to 20
ml with mobile phase.
Procedure: Inject one blank, five replicate injection of standard solution, two replicate injection of sample solution & two bracketing standard solution.
System Suitability:
1) RSD of five
replicate injection of standard solution should not be more than 2.0%
2) RSD of five replicate injection of
standard solution and two bracketing standard solution should not be more than 5.0%
3) Tailing factor should not be more than 2.0
Calculation :
