Abstract

METHOD DEVELOPMENT AND VALIDATION OF PROPIVERIENE HYDROCHLORIDE CAPSULES BY REVERSE PHASE HPLC

Alekhya Somepalli*, Nanda Gopala Krishna Gona, Chanukya Senapathi, Naga Sailaja Chandolu, Valli Padma Chilaka and Sri Lakshmi Avutu

ABSTRACT

The present study was to develop and validate the assay of Propiveriene Hydrochloride capsules by the Reverse phase High Performance Liquid Chromatography (HPLC) with UV detector. The method was developed and validated according to ICH guidelines for its various parameters including System suitability and system precision, Specificity, Linearity, Range, Accuracy, System and Intermediate Precision, Limit of detection, Limit of Quantitation, Robustness, Bench top and refrigerator (2-8°C) solution stability, Bench top stability of mobile phase. Based on this Method, the assay of Propiveriene hydrochloride capsules were precised, lineared and accurated in the range of 25%-200% of test concentration of 45mg capsules. % assay and % RSD of six samples were calculated and found to be within the acceptance criteria. System suitability parameters were found to be within the specified limits and RT of the main peak was monitored for 50:50%v/v (Water: Methanol).

Keywords: RP-HPLC, Mobile phase, Stationary phase, Propiveriene Hydrochloride, UV detector.