Abstract

SIMPLE AND STABILITY INDICATING RP-HPLC ASSAY METHOD DEVELOPMENT AND VALIDATION NAFTOPIDIL BY RP-HPLC IN BULK AND DOSAGE FORM

Dr. K. Raghu Babu, E.S.R.S.Sarma*, Dr. G.M.J.Raju, Dr.G.V.S.Sarma, Dr. N. Aruna Kumari

ABSTRACT

A new simple, accurate, precise, sensitive and validated RP-HPLC method was developed for the estimation of Naftopidil in bulk and pharmaceutical dosage form. The Chromatographic conditions used for the separation was Zorabax SBC18 (150x4.6 MM, 5μ) and the mobile phase comprised of Acetonitrile and Ammonium Acetate (75:25 v/v). The flow rate was 1.2 mL/min. The detection was carried out at 232 nm. The Assay method was validated as per ICH guidelines. The linearity was found to be in the range of 0.1 – 0.6 mg/ml (25% to 150%) with correlation coefficient(r) 0.9946. The proposed method is accurate with 99.77% - 99.98% recovery for Naftopidil and precise. (%RSD of repeatability, intraday and inter day variations were 0.267 - 0.621. The method can be successfully applied to pharmaceutical formulation.

Keywords: Naftopidil, Ammonium Acetate, RP-HPLC, Method development and validation.