Abstract
ObjectiveThe objective of the present work is to develop a simple, precise, accurate, validated stability indicating RP-HPLC method for the determination of Atazanavir sulphate in bulk and capsule dosage form. MethodA validated stability indicating RP-HPLC method for the estimation of Atazanavir sulphate in capsule dosage form on Agilent TC C18 (2) 250 × 4.6 mm, 5 μ column using mobile phase composition of 0.02 M ammonium dihydrogen phosphate buffer:acetonitrile:methanol (30:25:45 v/v) and pH adjusted at 2.5 with ortho-phosphoric acid. Flow rate was maintained at 1 ml/min at an ambient temperature. Quantification was achieved with ultraviolet detection at 288 nm. ResultsThe retention time obtained for Atazanavir sulphate was at 3.0 min. The result obtained with the detector response was found to be linear in the concentration range of 5–50 μg/ml. This method has been validated and shown to be specific, sensitive, precise, linear, accurate, rugged, robust and fast. Atazanavir sulphate was subjected to different accelerated stress conditions. The degradation products, when anywhere well resolved from the pure drug with significantly different retention time values. ConclusionIt is concluded that this method can be applied for routine quality control of Atazanavir sulphate in capsule dosage forms as well as in bulk drug.
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