RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF DESVENLAFAXINE SUCCINATE BULK DRUG IN ARTIFICIAL URINE

Desvenlafaxine (DSV) succinate is a novel serotonin (5HT) and nor-epinephrine reuptake inhibitor (SNRI), which is currently used for the treatment of major depressive disorders and is being studied for use in the management of vasomotor symptoms in postmenopausal women. DSV is a major active metabolite of venlafaxine. DSV has only 30 % of protein binding and approximately 45% of the total oral dose of DSV is excreted unchanged in the urine. The chromatographic separation was performed with acetonitrile and phosphate buffer in the ratio of 25:75 (v/v) at a flow rate of 1 ml/min with UV detection at 224 nm. The extraction was done using C8 solid phase cartridges. The method is validated for precision, linearity, recovery and stability as per the USFDA guideline and the results met the acceptance criteria. The linear regression analysis data for the calibration plots showed a good linear relationship (R2 = 0.995) over a concentration range of 5-30 ppm. The percentage relative standard deviation (% RSD) values of precision were