QUAL ITY CONTROL DEPARTMENT

SPECIFICATION AND TESTING METHOD FOR

FASXIME CAPSULES 400mg

PRODUCT SPECIFICATIONSContents: Cefixime (as trihydrate) USP ………. 400 mg.Description: Light yellow color granular powder, filled in Hard Gelatin Capsule Shell with dark

pink color body and black color cap.Pack Size: 1 x 5’sWeight Variation: Complies with USP limitsAssay Limits: 90-110%

IDENTIFICATION:The UV-Visible spectrum of sample solution is similar to that of standard solution.

ASSAY:Sample solution: Remove the contents of 20 capsules as completely as possible. Weigh powder equivalent to 100mg of Cefixime (in case of bulk granules, weigh granules equivalent to 100 mg of Cefixime) and transfer to 100 ml volumetric flask containing 10 ml of mixed phosphate buffer pH 6.8. Gently shake for 2-3 minutes. Add 60 ml of distilled water and sonicate for 10 minutes. Cool the solution, if hot, to room temperature and dilute to 100 ml with distilled water. Stir the solution for 15 minutes with the help of a magnetic stirrer. Filter the solution and take 1 ml of the filtrate in to 100 ml volumetric flask containing 5 ml of mixed phosphate buffer pH 6.8 and dilute to 100 ml with distilled water.

Standard solution: Dissolve 111.9 mg of Cefixime trihydrate, equivalent to 100 mg of Cefixime in a mixture of 10ml mixed phosphate buffer and 10ml distilled water and dilute to 100 ml with distilled water. Filter, if necessary, and take 1 ml of the filtrate in to 100 ml volumetric flask containing 10 ml of mixed phosphate buffer pH 6.8 and dilute to 100 ml with distilled water.Procedure: Measure the absorbance of both sample and reference solutions and deduce the result by comparison. Preparation of Mixed Phosphate Buffer pH 6.8:Dissolve 28.80 g of disodium hydrogen orthophosphate and 11.45 g of potassium dihydrogen orthophosphate in sufficient water to produce 1000 ml.

Final concentration of Sample and Reference solution: 0.01 mg/ml.Wavelength (max): 288 nm.Blank: Dilute 5ml of phosphate buffer to 50ml with distilled water.