Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF A NEW RP-HPLC METHOD FOR THE ESTIMATION OF VENLAFAXINE HYDROCHLORIDE AND THE RELATED SUBSTANCES IN CAPSULE DOSAGE FORM

Dr. Ch. Saibabu*, G. Naga Jyothirmai, Dr. M. Bhaskar

Abstract

A simple, accurate, precise and validated new RP-HPLC method for determination of Venlafaxine Hydrochloride has been developed. Analysis was carried out on Shimadzu HPLC system with Inertsil ODS- 3V C18 column, (150mmx4.6mm, 5 μm) using filtered and degassed solutions containing a mixture of buffer and methanol (55:45) in isocratic mode as mobile phase with flow rate of 1.0mL/ minute. The detection was carried out using UV detector set at 225nm. The method, obeyed Beer’s law in the concentration range of linear from 80% - 120% of Venlafaxine Hydrochloride. The method was validated in terms of linearity, precision, accuracy, and specificity, limit of detection and limit of quantification. The procedure is simple, reproducible, cheap and less time consuming. To Validate the RP-HPLC method used for the analysis of related substances present in Venlafaxine Hydrochloride and to demonstrate that the method is appropriate. The HPLC method used for determination of related substances in Venlafaxine Hydrochloride has been developed in house at Ra Chem Pharma ltd. The method needs to be validated in order to give evidence of its reliability and suitability. The validation will be performed according to the current requirements as laid down in the ICH Guidelines Q2 (R1). Analysis was carried out on Shimadzu HPLC system with Column: Altima C8, 250 mm x 4.6 mm, 5µm using filtered and degassed solutions containing a mixture of buffer and ACN (1490:510) in isocratic mode as mobile phase with flow rate of 1.2mL/ minute. The detection was carried out using UV detector set at 225nm. The method was validated for impurity -F in terms of linearity, precision, accuracy, and specificity, limit of detection and limit of quantification. The percentage recovery 100.76% from the capsule formulation. The results obtained in this study demonstrate that the Venlafaxine Hydrochloride HPLC method described in the protocol is selective, linear, precise, rugged and robust for the determination of Related Substances in Venlafaxine Hydrochloride drug.

Keywords: Venlafaxine hydrochloride, antidepressant, RP-HPLC, validation.