Pragati R. Kamble, Nikita V. Pandagale, Omkar D. Ghatage, Pramod B. Patil, S. Patil
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引用次数: 0
摘要
建立了一种准确、专属性、精密度、高效液相色谱法测定非布司他原料药及其片剂剂型的方法。以乙腈:甲醇(70:30)为流动相，流速为1.0ml/min，采用Symmetry C18色谱柱Finepack SIL C18T-5 (250x4.6mm, 5m)。流出物在314nm处进行光谱监测。在不同浓度水平下，日、日间精密度的变异系数在0.62% ~ 2.78%之间。校正曲线呈线性，相关系数为0.9947。相对加样回收率为98.67% ~ 98.96%。所建立的高效液相色谱法可用于定量非布司他原料药和剂型的质量控制。
Development and Validation of RP-HPLC Method for Determination of Febuxostat in Bulk and Pharmaceutical Dosage Formulations
A new accurate, specific, precise, high performance liquid chromatographic (HPLC) method has been developed and validated for the determination of Febuxostat in bulk and in its pharmaceutical dosage forms of tablet. Acetonitrile: Methanol (70:30) was used as the mobile phase at a flow rate of 1.0ml/min using a Symmetry C18 column Finepack SIL C18T-5 (250x4.6mm, 5m). The effluent was spectroscopically monitored at 314nm. The intraday and inter-day precisions showed coefficients of variation ranged from 0.62% to 2.78% at different levels of concentrations. The calibration curve was linear with a correlation coefficient of 0.9947. The averages of the absolute and relative recoveries were found to be 98.67% to 98.96%. The proposed HPLC method was successfully applied to quantify the amount of Febuxostat in bulk and dosage forms in quality control.
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