Development And Validation of a Stability-Indicating RP-HPLC Assay Method for Atazanavir Sulfate in Bulk Drug and Capsule Dosage Form, and Its Application In Dissolution Studies

Abstract

This research aimed to develop and validate a stability-indicating RP-HPLC method for the quantitative estimation of Atazanavir sulfate in both bulk drug and capsule dosage forms. The method's specificity was established through stress tests, demonstrating its ability to accurately quantify Atazanavir sulfate in the presence of potential degradation products. Validation parameters including linearity, accuracy, precision, and robustness were assessed in accordance with ICH guidelines, confirming the method's reliability and suitability for routine pharmaceutical analysis. Additionally, the developed RP-HPLC method was applied to conduct a dissolution study of Atazanavir sulfate capsules, providing valuable insights into its dissolution behavior under specified conditions. The dissolution method was validated for linearity, precision, and accuracy, further supporting its applicability for dissolution testing purposes. Results from the stability-indicating RP-HPLC method revealed the drug's stability under various stress conditions, with significant degradation observed only in base degradation. The dissolution study highlighted the drug's consistent release profile over the specified time intervals. Overall, the developed methods offer reliable and specific means for the quantitative analysis and dissolution testing of Atazanavir sulfate, contributing to pharmaceutical quality control and stability assessment. These methods are poised to facilitate routine analytical procedures in pharmaceutical laboratories, ensuring the quality, safety, and efficacy of Atazanavir sulfate-based products.