Abstract

NEW ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR ANTIVIRAL DRUG (SOFOSBUVIR) IN BULK DRUG AND DOSAGE FORMS

Rikshaya Tamang*, Dr. C. Sreedhar, Akkamma H. G., Katikala Dharmendra, Kripa Shrestha and Mohamed Adam Ahmed Mohamed

ABSTRACT

A simple, sensitive, precise, and accurate isocratic reverse phase high pressure liquid chromatographic method has been developed and validated for the estimation of sofosbuvir in bulk and tablet dosage form. To optimize, a column Eclipse plus-C8 (150 mm x 4.6 mm, 5 μm), mobile phase mixture acetonitrile: ammonium acetate as buffer having pH of 3.7 in the ratio of (50:50 v/v) was found to be an efficient system for elution of drug with good peak shape as well as retention time 2.220 min., flow rate 1.0 ml/min. at UV wavelength of 257nm. Quantitative linearity was obeyed in the concentration range of 1-32 μg/ml, the regression equations of concentration over their peak areas were found to be Y = 830031x + 575606 R² = 0.9992, where Y is the peak area and X is the concentration of drug. The number of theoretical plates obtained was 2604.352 which indicate the efficient performance of the column. The limit of detection was 0.106 μg/ml and limit of quantification was 0.355 μg/ml, which indicates the sensitivity of the method the high percentage recovery indicates that the proposed method is highly accurate. No interfering peaks were found in the chromatogram indicating that excipients used in tablet formulation did not interfere with the estimation of the drug by the proposed RP-HPLC method.

Keywords: Sofosbuvir, RP-HPLC and method development.