帕唑帕尼原料药及其剂型的反相高效液相色谱法研究

Kiran Kumar Buralla, V. Parthasarathy
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引用次数: 0

摘要

目的:建立一种准确、灵敏、精确、快速的反相高效液相色谱法(RP-HPLC)分析和定量帕唑帕尼的方法。对帕唑帕尼原料药和制剂进行了分析和定量。方法:以Phenomenex enable C18色谱柱(15x4.6mm,粒径5μm)为固定相,对Pazopanib原料药和制剂进行分析。流动相为乙腈与磷酸盐缓冲液(pH 5),比例为60:40%v/v,流速为1.2ml/min。采用PDA检测器对洗脱液进行分析,检测波长为290nm。该方法按照ICH指南《分析方法验证:文本和方法学Q2 (R1)》进行验证。结果:本研究中,Pazopanib色谱峰具有良好的分辨率,保留时间为2.190min。Pazopanib具有良好的线性关系,相关系数为0.998。其他验证参数包括精密度、特异性、准确性和鲁棒性,表明Pazopanib的定量具有良好的可靠性。结论:该方法可方便地用于巴唑帕尼原料药和制剂的定量分析。该方法也可用于多组分药物分析。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Validated RP-HPLC Method Development of Pazopanib in Bulk and its Pharmaceutical Dosage Form
Objectives: An accurate, sensitive, precise and rapid method for analysis and quantification of Pazopanib by Reverse Phase High Performance Chromatography (RP-HPLC) was developed and validated. Pazopanib in bulk and formulations were analyzed and quantification. Methods: Pazopanib in bulk and formulations were analyzed on Phenomenex enable C18 column (15x4.6mm, 5μm particle size) as stationary phase. Mobile phase was composed of acetonitrile and phosphate buffer (pH 5) in the ratio of 60:40%v/v at a flow rate of 1.2ml/min. elutes were analyzed using PDA detector at a detection wavelength of 290nm. The proposed method was validated by ICH guidelines, Validation of Analytical Procedures: Text and Methodology Q2 (R1). Results: In this study, the chromatographic peaks of Pazopanib showed good resolution with retention time of 2.190min. Pazopanib showed an excellent linearity with 0.998 of correlation coefficient. Other validation parameters including precision, specificity, accuracy and robustness demonstrated good reliability in the quantification of Pazopanib. Conclusion: Thus the newly developed and validated method can be conveniently used for the quantification of Pazopanib in bulk and formulation. The method can also be applied to multi-component drug analysis.
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