Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF NAFTOPIDIL IN BULK AND DOSAGE FORM USING RP HPLC

Shruti Bika*, Prashant Purohit 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 C 18 using Pot. Dihydrogen o-phosphate: ACN in ratio of 35:65 at flow rate of 1.0 ml/min. Components are detected imultaneously at 232 nm using UV detector. The detection limits for Naftopidil was 0.094 μg/ml where as the quantitation limits was 0.28 μg/ml. Linearity range was established in range of 05–10 μg/ml for Naftopidil. Recovery of the added Naftopidil standard mixture in tablet solution was found 100.8 % 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.