Determination of Venlafaxine in Bulk and Pharmaceutical Formulations Using Stability Indicating RP-HPLC Method with UV Detector

Abstract

Background: A robust and validated analytical method is a key component at various stages of pharmaceutical product development to ensure identity, purity and quality of drugs and formulations. Objective: The aim of proposed work was to develop and validate a simple, sensitive and stability indicating high performance liquid chromatographic method for the estimation of venlafaxine hydrochloride in bulk and formulations for routine analysis as well as for preformulation studies. Methods: Efficient chromatographic separation has been performed on a HpyercloneTM 5µm BDS C18 column using a mobile phase consisting of a mixture of phosphate buffer (25 mM, pH 3.0) and acetonitrile (70:30 v/v) at a flow rate of 1 ml min-1. Venlafaxine hydrochloride was analyzed using UV detector at 225nm. Developed method was validated as per ICH guidelines. Results: The method has demonstrated linearity over the range of 100 to 2000 ng ml-1 with regression equation, mean peak area (y) = 93.32 x concentration - 322.00 (R2 = 1). The method has demonstrated good and consistent recovery (99.34 to 101.16%). Precision of the method reflected by the relative standard deviation values at intra-day and inter-day levels was less than 1.79%. The detection and quantitation limits were 6.55 ng ml-1 and 19.84 ng ml-1 respectively indicating sensitivity of the method. The method was successfully applied for the estimation of venlafaxine hydrochloride in marketed and inhouse formulations. Also, developed method was successfully used in drug-excipients compatibility studies for VEN. Conclusion: The method was found to be accurate, precise, sensitive and selective for the determination venlafaxine hydrochloride in bulk and pharmaceutical formulations.