Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR ENTECAVIR ORAL SOLUTION BY RP-HPLC METHOD

Prof. Vijay G. Rokade*, Dr. S. B. Bhawar, Prof. S. B. Kakad

ABSTRACT

The objective of the current study was to develop a simple, accurate, precise and rapid RP-HPLC method with subsequently validate as per ICH guidelines for the determination of Entecavirby using mobile phase [mixture of Buffer solution ph 5.0 and Acetonitrile in the ratio 80:20v/v respectively.]. The proposed method involves the measurement of Retention time at selected analytical wavelength. 254.0 nm was selected as the analytical wavelength. The retention time of Entecavir was found to be 6.8 min. respectively. The Linearity was evaluated in the range of 50% to 150% of the working concentration level. As the working concentration level of Entecavir is about 50 ppm for Entecavir oral solution 1mg. The Linearity of response was determined by preparing different concentrations of standard stock solution ranging from 50% of 50ppm to 150% of 50 ppm. The method was statistically validated for its linearity, accuracy and precision.

Keywords: RP-HPLC METHOD, Entecavir, Validation.