Development and Validation of Stability-Indicating High Performance Liquid Chromatographic Method for Determination of Tetramisole Hydrochloride in Pharmaceutical Formulation

Abstract

Objective: Development of simple and selective stability-indicating HPLC method for
determination of tetramisole hydrochloride in presence of its degradation products.
Method: Analysis was performed on SUPELCO C18 column (250mm length, 4.6mm
width, 5μm particle size) using acetonitrile : methanol : water (50:33:17, by volume) as
a mobile phase. The analysis process was carried out at ambient temperature with flow
rate of 1 mL/min and the separated peaks were detected by UV at 212 nm. Drug was
exposed to forced degradation condition like hydrolysis, oxidation, thermal and
photolysis. Results: Method can well resolve all degraded product as compare to
tetramisole hydrochloride. The method has been linear for the range of 1 – 6 μg/mL
with r2 0.9997. Conclusion: This work focused on study of the stability of tetramisole
hydrochloride and its behavior when exposed to different stress conditions. The
proposed method was successfully applied for determination of tetramisole
hydrochloride in pharmaceutical preparation without interference from excipients or
degradation products and the method was found to be valid according to International
Conference on Harmonization (ICH) guidelines.