Abstract

ANALYTICAL RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF NEVIRAPINE IN API AND PHARMACEUTICAL DOSAGE FORM

Bonagani Naresh*, Manda Rakesh, D. Pallavi, Ankam Rishwanth and Ravula Navya Sri

ABSTRACT

An accurate, precise, specific, simple and rapid RP-HPLC method was developed and subsequently validated for the determination of Nevirapine in API and Pharmaceutical dosage form. Better separation of the drug was achieved on Waters ODS (C18) RP Column, 250 mm x 4.6 mm. with a mobile phase consisting of a mixture of Methanol: Phosphate buffer in the ratio of 75:25 v/v at a flow rate of 1ml/min, with detection at 279nm using UV-Visible Detector. The developed method was validated for different parameters such as linearity, accuracy, precision, limit of detection (LOD), limit of Quantization (LOQ), robustness and the results were found to be within the limits according to ICH (International Conference on Harmonization) guidelines. The retention time of Nevirapine was found to be 3.462 min. The method was found to be linear in the range of 0- 14μg/ml with a correlation coefficient (r2) of 0.999. The LOD and LOQ of the method were calculated to be 0.003 and 0.009μg/ml respectively. The Precision was estimated by employing repeatability; intra-day and inter-day studies and the results were calculated as %RSD values and were found to be within the limits. The average recovery of the analyte was found to be within the limit which confirms the accuracy of the method.

Keywords: Nevirapine, RP-HPLC, Method Development, ICH Guidelines.