Validate a Stability Indicating RP- HPLC Method for Simultaneous Estimation of Univestin and UC-II in Bulk and Pharmaceutical Formulations

Abstract

A simple, rapid, precise, sensitive and reproducible reverse phase high performance liquid chromatography (RP-HPLC)(1) method has been developed for the quantitative analysis of Univestin and UC-II in pharmaceutical dosage form. Chromatographic separation of Univestin and UC-II was achieved on Waters Alliance-e2695 by using Chiral Cell ODH 150x4.6mm, 5μ column and the mobile phase containing Hexane + THF and 0.1% Formic Acid in the ratio of 80:20% v/v. The flow rate was 1.0 ml/min; detection was carried out by absorption at 308nm using a photodiode array detector at ambient temperature. The number of theoretical plates and tailing factor for Univestin and UC-II were NLT 2000 and should not more than 2 respectively. % Relative standard deviation of peak areas of all measurements always less than 2.0. The proposed method was validated according to ICH guidelines. The method was found to be simple, economical, suitable, precise, accurate & robust method for quantitative analysis of Univestin and UC-II study of its stability.