Abstract

DEVELOPMENT AND VALIDATION OF RP HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF DESVENLAFAXINE AND CLONAZEPAM IN TABLET DOSAGE FORM

Krupa M. Patel*,Jayant B Dave, Nadim M. R. Chhipa

ABSTRACT

A simple, rapid, precise and accurate RP-HPLC method was developed and validated for simultaneous estimation of Desvenlafaxine and Clonazepam in their combined tablet dosage form. This method was developed using Phenomenex (150mm×4.6mm,5μmparticlesize) and Methanol:Acetonitrile:20mM Ammonium acetate buffer pH (30:20:50 v/v/v) as the mobile phase at 0.8 mL/minflow rate with detection at 222 nm. The average retention times for Desvenlafaxine and Clonazepam were found to be 3.080 and 8.842 min respectively. Validation of the method was carried out as per ICH guidelines. Linearity was established for Desvenlafaxine and Clonazepam in the range of 100-600μg/mL and 1-6μg/mL respectively. Correlation coefficient was found to be 0.9985 and 0.9994 for Desvenlafaxine and Clonazepam respectively. The percentage recovery of Desvenlafaxine and Clonazepam was found to be in the range of 99.85-101.13% and 99.72-101.67% respectively.Desvenlafaxine and Clonazepam and their combination drug product were subjected to acid hydrolysis, base hydrolysis, oxidation, thermal and photolytic stress conditions. The method successfully separated both the drugs from potential degradation products in stress samples with adequate peak purity establishing specificity and stability indicating nature of the method. The method was found to be specific and stability indicating as no interfering peaks of degradants and excipients were observed.

Keywords: Desvenlafaxine, Clonazepam, Forced degradation study, RP-HPLC.