Development and Validation of UV Spectroscopy Method for the Estimation of Dolutegravir in Bulk and Pharmaceutical Dosage Form

Vaishnavi Dulange, G. Gajeli
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引用次数: 2

Abstract

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.
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
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。
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