Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR NEVIRAPINE TABLET DOSAGE FORM

Vedigounder Murugan*, Ravindra Vishal Singh, Pavan Kumar Puvvada, Geetha Mukundan Manisha Shukla, and Ashwini A. Kulkarni.

ABSTRACT

A simple, rapid, precise and sensitive R-HPLC method for analysis of bulk drugs nevirapine and its degraded compounds has been developed. The method has been validated for the estimation of bulk drugs. Chromatography was carried out using C18 column having 25 cm × 4.6 mm internal diameter and 5μ particle size. The mobile phases include 70:30 (v/v) acetonitrile: ammonium acetate buffer respectively, pH was adjusted to 4 ± 0.1 with 5% orthophosphoric acid and glacial acidic acid. The flow rate was 1 ml/min. λ max for the drug was 223 nm by UV. The retention time for the drugs was 3.1 min. The method developed was validated in accordance with ICH guidelines and it was reproducible. The linearity range was 20-100 μg/ml for the drug. The LOD and LOQ was 0.25 ng/ml and 0.76 ng/ml respectively. The high recovery and low coefficients of variation confirm the suitability of this method for analysis of the above drug. A acid hydrolysis, alkali hydrolysis, oxidative stress and water stress degraded compounds identified and analyzed by this method.

Keywords: Nevirapine, method validation, forced degradation, RP-HPLC.