Abstract

DEVELOPMENT AND VALIDATION OF Q-ABSORBANCE RATIO METHOD FOR THE SIMULTANEOUS ESTIMATION OF SOFOSBUVIR AND DACLATASVIR DIHYDROCHLORIDE IN SOLID DOSAGE FORM

Khushbu S. Bhavsar* and Paresh U. Patel

ABSTRACT

A simple and sensitive Spectrophotometric method based on Q-Absorbance Ratio Method was developed for the simultaneous estimation of Sofosbuvir and Daclatasvir dihydrochloride in solid dosage form. This method was based on the formation of Q- Absorbance equation at two wavelengths, one was Isoabsorptive Point and another one was λmax of one of them. So, λ1 was 273 nm and λ2 was 261 nm. and Daclatasvir dihydrochloride were comply with the Beer’s Lambert’s law over the linearity range 4-32 μg/ml. The method was validated as per International Conference on Harmonization (ICH) guidelines. The parameters of ICH guidelines are Linearity, Precision (Repeatability and Reproducibility), Limit Of Detection (LOD), Limit Of Quantitation (LOQ) and Accuracy. All parameters were found to be within the accepted limits. The method was found to be simple, rapid, sensitive, precise, accurate and cost effective for use in routine analysis of both drugs in pharmaceutical dosage form.

Keywords: Sofosbuvir, Daclatasvir dihydrochloride, Q-Absorbance Ratio method, Methanol: Water (50:50).