Abstract

A NEW RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF ATAZANAVIR AND RITONAVIR IN IT’S PURE AND PHARMACEUTICAL DOSAGE FORM AS PER ICH GUIDELINES

Santhosh Illendula*, Kandhagatla Saisneha, V. Shirisha, Dr. K. N. V. Rao, Dr. K. Rajeswar Dutt

ABSTRACT

A simple, accurate, robust, specific and precise Reverse phase HPLC method was developed for the simultaneous estimation of the Atazanavir and Ritonavir in pure and pharmaceutical dosage form as per ICH Guidelines. Chromatogram was run through Phenomenex Luna C18 (4.6mm×150mm, 5μm) Particle size column and Mobile phase containing Methanol: Tri Ethyl Amine Buffer (35:65% v/v) was pumped through column at a flow rate of 1.0ml/min. Temperature was maintained at 38°C. Optimized wavelength selected was 261nm. Retention time of Atazanavir and Ritonavir were found to be 2.256min and 5.427min. The developed method was validated in terms of accuracy, precision, linearity, limit of detection, limit of quantification. The proposed method optimized and validated as per ICH guidelines. The Precision of the %RSD of the Atazanavir and Ritonavir were and found to be 0.212 and 0.064 respectively. %Recovery was obtained as 100.36% and 100.15% for Atazanavir and Ritonavir respectively. LOD, LOQ values obtained from regression equations of Atazanavir and Ritonavir were found to be 2.63, 3.84 and 7.92, 11.54 respectively. Regression equation of Atazanavir is y = 10511x + 9597 and y = 6120x + 29119 of Ritonavir. The proposed method can be used for the estimation of these drugs in pure and its pharmaceutical combined dosage forms.

Keywords: Atazanavir, Ritonavir, RP-HPLC, Validation, ICH Guidelines.