Oxyclozanide
(Finished product) Tablet Assay (By HPLC)
Standard Preparation
Take 300 mg of Oxyclozanide WS in 100 ml volumetric
flask and add 80 ml methanol, sonicate to dissolve and make up volume upto mark
with methanol. Take 5 ml of the solution and dilute to 10 ml with methanol
Sample Preparation
Weigh sample
equivalent to 300 mg of Oxyclozanide in 100 ml volumetric flask add 80 ml of
methanol and sonicate for 30 minutes, and make up volume upto mark with
methanol and filter through whatman filter paper no. 41.
Take 5 ml of the filtrate solution and dilute to 10 ml with methanol.
Chromatographic Conditions :
Column -C18 (20 cm x 4.6 mm) 5ยต or
equivalent
Flow rate - 2.0
ml/min.
Detectorwavelength - 300 nm
Injection
volume - 20ml.
Column
Temp - 25°C
Mobile
Phase - Buffer
Buffer Preparation: 62 % of
methanol and 38 % of 0.1 % of phosphoric acid.
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 2.0%
3) Tailing factor should not be more than 2.0
Calculation :
