RP-HPLC Method for Estimation of Tiapride Related Subtance in Tablet Formulation

Abstract

A reverse phase high-performance liquid chromatographic (rp-hplc) method was developed for the quantitative estimation of impurities which are present in tiapride tablets. The method developed using Inerstil C8 (250 × 4.6) mm, 5μ column. Mobile phase used in the method was mixture of Buffer:Acetonitril:Methanol (800:150:50) where the phosphor buffer 0.05 m with pH 2.7 was used. The column eluted was monitored at 240 nm. The retention time of tiapride was found about 8.5 min. Tiapride was subjected to various stress condition to obtain degradation product. The developed method shows well resolved degradation product from tiapride hydrochloride tablet and from each others too. The method was validating as per ICH and it shows that it is Accurate, Precise, and Robust for formulation analysis.