Development and validation of a stability-indicating RP-HPLC method for estimation of atazanavir sulfate in bulk

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Atazanavir sulfate is a crucial antiretroviral medication.
• Ensuring the stability and quality of atazanavir sulfate in tablet formulations is essential for patient safety and therapeutic efficacy.

Purpose of the Study:

• To develop and validate a stability-indicating analytical method for quantifying atazanavir sulfate in tablet dosage forms.
• To assess the degradation profile of atazanavir sulfate under various stress conditions.

Main Methods:

• A reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed using a C18 column.
• The mobile phase consisted of methanol and water (90:10 v/v) buffered at pH 3.55 with acetic acid.
• Method validation was performed according to International Council for Harmonisation (ICH) guidelines, including linearity, specificity, and stress testing.

Main Results:

• The developed RP-HPLC method demonstrated good linearity over the concentration range of 10–90 μg/mL (R² = 0.999).
• Atazanavir sulfate exhibited its highest sensitivity to degradation under acidic conditions.
• The retention time for atazanavir sulfate was determined to be 8.323 minutes at a detection wavelength of 249 nm.

Conclusions:

• A robust and validated stability-indicating RP-HPLC method has been successfully established for the analysis of atazanavir sulfate in tablet formulations.
• The findings provide critical insights into the stability characteristics of atazanavir sulfate, particularly its susceptibility to acidic environments, aiding in formulation development and storage recommendations.