Research scholar, Department of Pharmacy, Shyam university, Dausa-303511, Rajasthan, India.
Principal and Professor, Department of Pharmacy, Shyam university, Dausa-303511, Rajasthan, India.
Zhongguo Ying Yong Sheng Li Xue Za Zhi. 2024 Aug 6;40:e20240018. doi: 10.62958/j.cjap.2024.018.
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.
已经开发和验证了一种分析、准确、精密、专属性强、高效且简单的超高效液相色谱法，用于测定原料药和市售药物制剂中的帕唑帕尼。用于色谱运行的流动相由 0.1%OPA 缓冲液和乙腈以 30:70%v/v 的比例组成。在 BHEL UPLC 柱上采用等度模式实现分离。帕唑帕尼药物峰得到了很好的分离，并在 256nm 处通过 PDA 检测器进行检测。所开发的方法在 6-14μg/ml 浓度范围内对帕唑帕尼具有线性。该方法已经根据 ICH 指南进行了系统适用性、专属性、精密度、准确度和稳健性验证。帕唑帕尼的 LOD 和 LOQ 分别为 0.5853µg/ml 和 1.7738µg/ml。所开发的方法简单、精确、专属性强、准确且快速，适用于原料药和市售药物制剂中帕唑帕尼的定量测定。
