Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPLC METHOD FOR ESTIMATION OF RAMOSETRON HCl

Zarana M Patel*, Mr. Darshil B. Shah, Dr. Dilip G Maheshwari

Abstract

A simple, specific, accurate, and stability indicating high-performance liquid chromatographic method was developed for the determination of Ramosetron HCl, using a Enamel C18 column and a mobile phase composed of Methanol:Water (50:50). The retention time of Ramosetron HCl found to be 3.59 min. Linearity was established for of Ramosetron HCl in the range of 200-600 ng/ ml. The percentage recoveries of was found to be in the range of 98.33-98.86 %. The drug was subjected to acid and base hydrolysis, oxidation, photolytic, and thermal degradation conditions. The degradation products of Ramosetron HCl were well resolved from the pure drug with significant differences in their retention time values. This method can be successfully employed for quantitative analysis of Ramosetron HCl in pure and tablet.

Keywords: Ramosetron HCl, degradation products, stability - indicating method, HPLC.