A new analytical method development and validation for the quantitative estimation of atazanavir in bulk form and marketed pharmaceutical dosage form by using RP-HPLC
Keywords:Atazanavir, RP-HPLC, Method Development, Validation, Accuracy.
Atazanavir is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 3 months of age and older weighing at least 5kg. Here an accurate, valid, elementary, and error-free reverse-phase liquid chromatography strategy was developed for the quantitation of Atazanavir in its bulk form as well as in marketed pharmaceutical dosage form. Effective chromatographic separation of Atazanavir was achieved by using waters, C-18, (250mm*4.6mmØ) column using Phosphate buffer (pH 3.0) and Acetonitrile in the proportion of 20:80 v/v. The Mobile phase was siphoned at a flow rate of 1.0 mL min-1 with a column temperature of ambient, and detection wavelength was carried out at 227 nm. The retention time was found to be 3.51 min for Atazanavir. The dimensionality of Atazanavir was in linear range with a parametric static of 0.9935. Method Validation was carried out in terms of Specificity, Linearity, Precision, Accuracy, LOD, and LOQ as per ICH Guidelines. Results obtained from the validation studies show that the developed method can be useful in the quality control analysis of bulk and marketed pharmaceutical formulations of Atazanavir.