紫外光谱法测定原料药和制剂中多替格拉韦含量的建立与验证

Vaishnavi Dulange, G. Gajeli
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引用次数: 2

摘要

建立了紫外分光光度法测定多替替韦原料药和制剂的含量。Dolutegravir在甲醇和水混合物中的紫外光谱在254nm处出现λ max。Beer定律在10-50µg/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、定量限和定量限的验证。该方法在10 ~ 50µg/ml范围内线性良好,回归方程为y = 0.030x + 0.008,回归相关系数r2= 0.998。检测限为2.056μg/ml,定量限为6.230μg/ml,具有较高的灵敏度。结果表明,该方法可成功地应用于制剂中多替格拉韦的含量测定。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Development and Validation of UV Spectroscopy Method for the Estimation of Dolutegravir in Bulk and Pharmaceutical Dosage Form
UV spectroscopic method was developed for the estimation of Dolutegravir in bulk and Formulation.The UV spectrum of Dolutegravir in methanol and water mixture showed λ max at 254nm. Beer’s law is valid in the concentration range of 10-50µg/ml. This method was validated for linearity, accuracy, precision, LOD and LOQ. The method has demonstrated excellent linearity over the range of 10-50µg/ml with regression equation y = 0.030x + 0.008 and regression correlation coefficient r2= 0.998. Moreover, the method was found to be highly sensitive with LOD (2.056μg/ml) and LOQ (6.230μg/ml). Depending on results the given method can be successfully applied for assay of Dolutegravir in formulation.
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