Abstract

RP-UFLC METHOD DEVELOPMENT AND VALIDATION FOR NEVIRAPINE IN BULK DRUG AND DOSAGE FORMS AS AN ANTIHIV AGENT

N. K. Sathish* and E. K. Anvar

Abstract

A simple, precise, rapid, accurate and reproducible RP-UFLC method has been developed and validated for the determination of Nevirapine in bulk drug and pharmaceutical dosage forms. An Eclipse plus C-8 column with a particle size of 5μm having an internal diameter of 4.6 х 250 mm was used in gradient mode. The mobile phase consisting of Methanol and Acetonitrile in the ratio of 90:10 v/v was used. The flow rate was set to 1ml/min and the detection was carried out at a wavelength of 214nm. The retention time was found to be at 2.7min and the linearity was found in the range of 2-10μg/ml with a correlation co-efficient value of 0.9996. The mean recoveries were found to be in the range of 98.51-101.80% and the % RSD reported was not more than 2. The LOD and LOQ values were found to be 0.021μg/ml and 0.063μg/ml respectively. Hence, the proposed method can be successfully applied for the quantitative determination of Nevirapine in the bulk drug and Pharmaceutical dosage forms.

Keywords: Nevirapine, RP-UFLC, Validation, ICH.