RELATED SUBSTANCES METHOD DEVELOPMENT AND VALIDATION OF ATAZANAVIR AND RITONAVIR IN TABLET DOSAGE FORM BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

Abstract

A simple, rapid, selective and stability indicating reversed High performance liquid chromatography method was developed and validated for the simultaneous quantification of process related and degradation impurities present in Atazanavir and Ritonavir tablets. The two proposed drug components and their respective impurities were separated using ACE C18 (250 mm x 4.6 mm), 5µm and mobile phase comprised of Buffer (pH 3.3) and Ogranic solvent in gradient proportion.The flow rate was 0.9ml/min.The detector wavelength of 240nm was used for quantifying the impurities.The selected chromatographic conditions were found to effectively quantitate Atazanavir and Ritonavir and its related impurities. Linearity and range were eatablished from LOQ level to 150% level. Accuracy of the method was established from LOQ level to 150% level.The developed stability indicating method is capable for determination of impurities of Atazanavir and Ritonavir in combined dosage form as well as individual forms also.