达沙替尼原料药和制剂的紫外分光光度法开发与验证

Jyoti Mittha, Bhavana Habib
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引用次数: 4

摘要

建立并验证了紫外分光光度法对达沙替尼原料药和制剂的定量评价。达沙替尼可溶于乙腈,所以用它作为溶剂。将达沙替尼溶解于乙腈中,在200-400nm紫外波段扫描。λmax为315nm。比尔斯定律在5-25µg/ml的浓度范围内有效。对该方法进行了线性度、准确度、精密度、鲁棒性验证;LOD和LOQ。在5 ~ 25µg/ml范围内呈线性关系,相关系数为0.9992。定量限和定量限分别为0.908µg/ml和2.752µg/ml。方法重现性好,回收率高;该方法可用于达沙替尼原料药和制剂的常规分析。
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UV Spectrophotometric Method Development and Validation of Dasatinib in Bulk and Formulation
UV-Spectrophotometric method has been developed and validated for quantitative estimation of dasatinib in bulk and pharmaceutical formulation. Dasatinib is soluble in acetonitrile, so it was used as solvent. Dasatinib was dissolved in acetonitrile and resulting solution was scanned in UV range (200-400nm). The λmax was found to be 315nm. Beers law is valid in concentration range of 5-25µg/ml. The developed method was validated for linearity, accuracy, precision, robustness; LOD and LOQ. Linearity was obtained in the range of 5-25µg/ml with correlation coefficient 0.9992. LOD and LOQ were found to be 0.908µg/ml and 2.752µg/ml respectively. The method showed good reproducibility and recovery so; proposed method can be applied for routine analysis of dasatinib in bulk and pharmaceutical formulation.
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