Thursday, 8 July 2021

Dexamethasone phosphate Injection Assay (By HPLC ) Finished Product | Test Procedure | Method of analysis (MOA) |


 

Dexamethasone phosphate Injection Assay (MOA) By HPLC


Mobile phase: To 1.360 gm of potassium dihydrogen phosphate add 0.600 g of hexylamine, mix, allow to stand for 10 minutes, dissolve in 182.5 ml of water, add 67.5 ml of acetonitrile, mix and filter (0.45 µm).

Standard Preparation

Weigh 131.60 mg of Dexamethasone phosphate WS equivalent to 100 mg of Dexamethasone in 100 ml volumetric flask, add 50 ml of mobile phase and sonicate to dissolve dexamethasone phosphate completely and dilute to 100ml with mobile phase. Shake well and further dilute 5 ml to 50 ml with mobile phase.

 Sample Preparation

Weigh and transfer injection equivalent to 10 mg of Dexamethasone In 100 ml of volumetric flask, add 50 ml of mobile phase, sonicate if required for 5 mins to dissolve dexamethasone phosphate completely and dilute to 100ml with mobile phase. Shake well

Chromatographic conditions

 Column                          - C18 (25 cm × 4.6 mm) (5 µm)

Flow Rate                       - 1 ml per minute.

Column Temperature  - Ambient

Detection wavelength - 254 nm.

Inject                                - 20 µL of each solution.

 

Determination of Content

Calculate the content of C22H29FO5 in the injection from the peak areas obtained and from the declared content of C22H30FO8P in dexamethasone phosphate. 1 mg of C22H30FO8P is equivalent to 0.831 mg of C22H29FO5.

Calculation