Abstract:
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.
摘要:
分析,准确,精确,具体,已开发并验证了高效,简单的超高效液相色谱法用于批量测定帕唑帕尼,并已用于市售药物剂型。用于色谱运行的流动相由0.1%OPA缓冲液和乙腈组成,比例为30:70%v/v。使用等度模式在BHELUPLC柱上实现分离。帕唑帕尼药物峰被很好地分离并且通过PDA检测器在256nm处检测。所开发的方法在6-14μg/ml的浓度范围内呈线性关系。该方法已根据ICH关于系统适用性的指南进行了验证。特异性,精度,准确性和鲁棒性。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,具体,准确快速,使其适合于估计散装和上市的药物剂型剂型中的帕唑帕尼。