Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ESTIMATION OF NAFTOPIDIL AS API AND IN TABLET DOSAGE FORM

Prashant Purohit*, Kruti Joshi and Yoshita Aggarwal

ABSTRACT

A reversed phase High Performance Liquid Chromatographic method for the estimation of Naftopidil has been developed. The drug was separated on ODS column using methanol and water as mobile phase in ratio of 80:20 v/v at flow rate of 0.8 ml/min. Components are detected simultaneously at 280 nm using UV detector. The detection limits for Naftopidil was 0.0327 μg/ml where as the quantitation limits was 0.0991 g/ml. Linearity range was established in range of 2–12 μg/ml for Naftopidil. Recovery of the added Naftopidil standard mixture in tablet solution was found 99.81 ± 0.384 with Relative standard deviation (n=3) of 0.384 %. The proposed method has been applied to the determination of Naftopidil in commercial products. The results obtained by methods were in good agreement of true values. The proposed method is simple, accurate, reproducible and suitable for routine analysis.

Keywords: Naftopidil , RP HPLC, ICH