Saturday 7 October 2017

Diclofenac sodium capsule (Assay) (By UV) | Finished Product | Test Procedure | Method of analysis (MOA) |
















Diclofenac Sodium/Capsule

Dissolve 6.8 g of potassium dihydrogen orthophosphate in 1000 mL of water and  adjust the pH to 6.8 with 1M sodium hydroxide (solution A). To a quantity of the  mixed contents of 20 capsules containing 50 mg of Diclofenac Sodium add 10 mL  of ethanol (96%) and mix with the aid of ultrasound for 20 minutes or until completely  dispersed. Add 150 mL of solution A and mix with the aid of ultrasound for a further  20 minutes or until completely dispersed. Cool to room temperature, dilute to 250 mL  with solution A and shake thoroughly. Filter the resulting solution and dilute 5 mL to 50 mL with solution A. Prepare a reference standard in the following manner.  Dissolve 50 mg of diclofenac sodium ws in 10 mL of ethanol  (96%) with the aid  of ultrasound for 5 minutes. Add 150 mL of solution A and mix with the aid of  ultrasound for a further 5 minutes. Cool to room temperature, dilute to 250 mL with  solution A and shake thoroughly. Dilute 5 mL of the resulting solution to 50 mL with  solution A. Measure the absorbance, of the solutions at 275 nm using  in the reference cell solution A.  
   
 Calculate the content of C14H10Cl2NNaO2 in the capsules using the absorbances at  the maximum at 275 nm and the declared content of C14H10Cl2NNaO2 in diclofenac sodium ws.



Calculation: