用于帕唑帕尼纯制剂和上市药品剂型定量估算的稳定性指示 UPLC 方法开发与验证

Q4 Medicine
Nerella Naveen Kumar, Shailesh Sharma
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引用次数: 0

摘要

本研究建立并验证了一种分析、准确、精确、特异、高效和简便的超高效液相色谱法,用于测定散装帕唑帕尼并将其应用于市场上的药物剂型。色谱流动相为 0.1% OPA 缓冲溶液和乙腈,体积比为 30:70%。在 BHEL UPLC 色谱柱上以等度模式进行分离。帕唑帕尼药物峰分离良好,采用PDA检测器在256 nm波长下检测。所建立的方法在帕唑帕尼 6-14 μg/ml 浓度范围内线性关系良好。该方法的系统适用性、特异性、精密度、准确度和稳健性均符合ICH指南的要求。帕唑帕尼的检出限(LOD)和定量限(LOQ)分别为 0.5853µg/ml 和 1.7738µg/ml。该方法简便、精确、特异、准确、快速,适用于帕唑帕尼散剂和市场上销售的药物剂型的检测。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Stability Indicating UPLC Method Development and Validation for the Quantitative Estimation of Pazopanib in Pure form and Marketed Pharmaceutical Dosage form.

An analytical, accurate, precise, specific, efficient and simple Ultra-Performance Liquid Chromatography method has been developed and validated for the determination of Pazopanib in bulk and was applied on marketed Pharmaceutical Dosage form. The mobile phase used for the chromatographic runs consisted of 0.1% OPA Buffer and Acetonitrile in the ratio of 30:70% v/v. The separation was achieved on a BHEL UPLC column using isocratic mode. Pazopanib Drug peak were well separated and were detected by a PDA detector at 256 nm. The developed method was linear at the concentration range 6-14 μg/ml for Pazopanib. The method has been validated according to ICH guidelines with respect to system suitability, specificity, precision, accuracy and robustness. The LOD and LOQ for the Pazopanib were found to be 0.5853 µg/ml and 1.7738µg/ml respectively. The developed method is simple, precise, specific, accurate and rapid, making it suitable for estimation of Pazopanib in bulk and marketed pharmaceutical dosage form dosage form.

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来源期刊
CiteScore
0.70
自引率
0.00%
发文量
53
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