Stability indicating RP-HPLC method for the determination of Atazanavir sulphate in bulk and dosage form

Drug Invention Today Pub Date : 2013-06-01 DOI:10.1016/j.dit.2013.05.008

Charushila H. Bhirud , Shivanand N. Hiremath

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引用次数: 8

Abstract

Objective

The 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.

Method

A 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.

Results

The 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.

Conclusion

It 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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稳定性指示反相高效液相色谱法测定硫酸阿扎那韦散装和剂型的含量

目的建立一种简便、精确、可靠、稳定的反相高效液相色谱法测定硫酸阿扎那韦散装和胶囊剂型的含量。方法在Agilent TC C18 (2) 250 × 4.6 mm, 5 μ柱上，采用流动相为0.02 M磷酸二氢铵缓冲液:乙腈:甲醇(30:25:45 v/v)，正磷酸调节pH为2.5，验证了反相高效液相色谱法测定硫酸阿扎那韦胶囊剂型的稳定性。在环境温度下，流速保持在1 ml/min。采用紫外分光光度288 nm进行定量。结果硫酸阿扎那韦的保留时间为3.0 min，在5 ~ 50 μg/ml浓度范围内与检测器的响应呈线性关系。该方法经过验证，具有特异性、敏感性、精确性、线性性、准确性、坚固性、鲁棒性和快速性。对硫酸阿扎那韦进行了不同加速应力条件下的研究。降解产物在任何地方都能很好地从纯药物中分离出来，其保留时间值存在显著差异。结论该方法可用于硫酸阿扎那韦胶囊制剂和原料药的常规质量控制。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Drug Invention Today

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