Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF SIMULTANIOUS ESTIMATION OF ATAZANAVIR AND RITONAVIR IN BULK AND PHARMACEUTICAL DOSAGE FORM BY USING RPHPLC

M. Khaja Vaheeda*, B. Thangabalan and Manohar Babu S.

Abstract

Quantitative estimation of Atazanavir and Ritonavir was estimated by RP-HPLC using ACN: 0.1% Ortho phosphoric acid (45:55%v/v) as a mobile phase and Hypersil column (250mm×4.6mm, 5μ) as a stationary phase and the peaks were observed at 240nm which was selected as a wavelength for quantitative estimation. After development of the method it was validated for specificity, system suitability, accuracy, linearity, precision, ruggedness and robustness. The linearity studies were performed for the standard and found to be linear. The accuracy has been determined from 50% to 150% and the prescribed limits for recovery are 85%-115%. From accuracy studies, % recovery was calculated and found to be within limits. The ruggedness of the method was checked on different systems and by different columns and standard was able to give same results which indicate that the method is rugged. The robustness of the method was checked by changing flow rate and temperature and standard was able to give system suitability parameters within limit, which indicates that the method is robust. Therefore it was concluded that the proposed method can be used for routine analysis of Atazanavir and Ritonavir tablet dosage forms.

Keywords: Atazanavir, Ritonavir, RP-HPLC, Specificity, System suitability, Accuracy, Linearity, Precision, Ruggedness and Robustness.