HPLC Method and Validation For The Determination Of Venlafaxine Hydrochloride in the Tablet Formulation

Abstract

For the analysis of venlafaxine hydrochloride in pharmaceutical dosage forms, a simple, precise, and reliable reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated. Chromatographic separation was achieved using a suitable C18 column with a mobile phase consisting of acetonitrile, methanol, with 0.1% hexane sulphonic acid in the ratio of 35:25:40 (v/v/v), with the pH adjusted to 3.1. At a controlled column temperature of 28°C, the analysis was carried out. Venlafaxine hydrochloride was eluted with a well-defined peak with a retention time of 3.411 minutes. With a correlation coefficient ,  of 0.9938, the method exhibited good linearity over the concentration range of 50%, 80%, 100%, 120%, and 150%. The method was validated guidelines show satisfactory results in the  method of  suitability, accuracy, precision, and robustness. The method developed was found to be reproducible and reliable, making it suitable for a routine venlafaxine hydrochloride quality control analysis. Venlafaxine hydrochloride recovery was found as 99.8%.