Abstract

METHOD DEVELOPMENT AND VALIDATION OF DOULTEGRAVIR API BY USING UV SPECTROCOPY METHOD

M. Rajyalaxmi*, Sudheshna Loka, N. Sandhya, Ch. Supraja and K. Sahithi

ABSTRACT

A simple, accurate, precise and rapid UV Spectrophotometric method was developed and validated for quantitative analysis of Dolutegravir API. UV Spectrophotometric method which involves the determination of Dolutegravir, the initial stock solution of Dolutegravir was prepared in the diluent i.e., 1% of orthophosphoric acid: Acetonitrile (60:40) and subsequent dilutions were done with the same diluent, and the standard solution showed the maximum absorption at wavelength 259.00nm. The drug obeyed Beer-Lambert’s law in the concentration range of 10μg/ml. The coefficient of correlation (r) was found to be 0.9995. It has showed good linearity, reproducibility, precision in the concentration range. The % Recovery values were found within 90%-110% showed that method was accurate. The LOD and LOQ were found to be 0.10μg/ml and 0.32μg/ml respectively. The % RSD values were less than 2. The validation parameters, tested in accordance with the requirements of ICH guidelines proves the suitability of this method. The developed method can be adopted in routine analysis of Dolutegravir and it involves relatively low-cost solvents and no complex extraction techniques.

Keywords: Dolutegravir, orthophosphoric acid, Acetonitrile, UV Spectrophotometer, method development and validation.