Abstract

A NOVEL ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTAENEOUS ESTIMATION OF ATAZANAVIR AND COBICISTAT BY USING RP-HPLC

K. Mangamma*, S. Sri Lakshmi, Guttula Suryavathi and Badugu Ameetha

Abstract

The present study is aimed to develop a simple, accurate, precise method was developed for the simultaneous estimation of the Atazanavir And Cobicistat dosage form by using RP-HPLC. Drugs were run through Xterra150,C18 (4.6mm, 5μ) column. Mobile phase containing Potassium dihydrogen Ortho phosphoric acid Methanol taken in the ratio 35:65 pumped through column at a flow rate of 0.8ml/min. Buffer used in this method was Potassium di hydrogen ortho Phosphate ortho phosphoric acid. Temperature was maintained at 25°C. Optimized wavelength for Atazanavir And Cobicistat 260 nm. Retention time of Atazanavir And Cobicistat were found to be 2.536min and 3.266 min. %RSD of the Atazanavir And Cobicistat were and found to be 1.52and 1.58 respectively. Linearity of the method was in the concentration range of 50-150% for Atazanavir and Cobicistat. % Recovery was Obtained as 100.0% for Atazanavir And Cobicistat respectively. The percentage RSD for precision of the method was found to be less than 2%. LOD, LOQ values were obtained from regression equations of Atazanavir And Cobicistat were 2.95ppm, 3.04ppm and 9.87ppm, 10ppm respectively. Regression equation of Cobicistat is y = 26773x + 2906, and of Atazanavir is y = 9958.7x + 959.67. Regression co-efficient of Cobicistat was 0.999.Regression co-efficient of Atazanavir was 0.999.The method was validated according to ICH guidelines.

Keywords: Atazanavir, Cobicistat, Methanol, potassium dihydrogen ortho phosphate.