Abstract

A SIMPLE STABILITY INDICATING ASSAY METHOD FOR ESTIMATION OF TRAPIDIL USING RP-HPLC

Atul T. Hemke*, Aparna A. Krupale and Krishna R. Gupta

Abstract

A simple validated stability indicating reverse phase high performance liquid chromatographic method has been developed for the determination of Trapidil. An isocratic separation was carried out using Princeton SPHR-100 C18 (250 x 4.6mm, 5μ) column using mobile phase comprises of Acetonitrile: Phosphate buffer pH 3.0 in ratio 50: 50 at flow rate 1mL/min using 221nm as detection wavelength. The Retention time for drug was found to be 4.178 ± 0.050min. The linearity was found to be in the concentration ranging 10-70μg/mL. The percent mean estimation of drug was nearly equal to 100%. The developed method was found to be more selective and rapid with respective shorter time. The force degradation studies were conducted and % of undegraded drug was calculated under various stress conditions via solution and solid state analysis. The stability study indicated degradation (not showing any additional peak) upon certain extend. The proposed new, simple validated stability indicating assay method was found suitable for routine analysis of Trapidil in dosage form.

Keywords: Trapidil, RP-HPLC, Stability indicating method, Stress degradation study.