DEVELOPMENT AND VALIDATION OF STABILITY INDICATING NEW RP-HPLC METHOD FOR THE DETERMINATION OF ATAZANAVIR SULFATE IN BULK AND CAPSULE DOSAGE FORM

Abstract

A new stability indicating RP-HPLC method was developed and validated for the determination of Atazanavir sulfate in bulk and capsule dosage form on Zorbax Eclipse XDB C18 (150x 4.6mm) 3.5 μm column. Elution was carried using mobile phase consists of phosphate buffer pH 6.5: acetonitrile (40:60 v/v) at column temperature of 30˚C. The flow rate of the mobile phase was maintained at 1 ml/min, and effluents were monitored by the PDA detector. Atazanavir sulfate was separated at the retention time of 3.9 min. The specificity of the method was determined by spiking major impurities like pyridinyl lactose acetal, 5-hydroxymethyl-2-furaldehyde, dealkyl atazanavir, and pyridinyl benzaldehyde into Atazanavir sulfate. Atazanavir sulfate was subjected to acid, base hydrolysis, peroxide oxidation, thermal and photolytic degradation. The stability studies indicated that Atazanavir sulfate was stable in acid, thermal, UV light while susceptible to alkaline hydrolysis and peroxide oxidation. Degraded products of peroxide and photolytic degradation coincide with the retention time of 5-hydroxymethyl-2-furaldehyde and pyridinyl benzaldehyde impurity, respectively. The new method is rapid, sensitive, linear, precise, accurate and without any interference of degraded products and excipients. Hence, the method can be successfully applied to the routine quality control of Atazanavir sulfate in bulk and capsule dosage form.