一种快速、经济、简便、有效的反相高效液相色谱法测定散装抗病毒药物索非布韦的含量

IF 0.4 Q4 CHEMISTRY, ANALYTICAL
I. Khan
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引用次数: 1

摘要

建立了一种简单、特异、准确、经济的反相液相色谱法,以乙腈和0.05M乙酸铵(pH7.6)为流动相,以50:50(v/v)的比例测定索非布韦的所有多晶型。索非布韦的对数校准曲线为10μg/mL至60μg/mL(r=0.9989),检测限(LOD)和定量限(LOQ)分别为0.245μg/mL和0.816μg/mL。所开发的方法经过高度验证和实践,可确保索非布韦原料具有可接受和无不良的准确性和精密度结果(回收率99–102%,RSD<1.2%,n=3)。所开发的RP-HPLC方法的总体结果之间无显著性差异(t检验)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A New, Rapid, Cost-Effective, Easy and Validated RP-HPLC Method for Determination of Antiviral (Sofosbuvir) in Bulk Forms
A simple, specific, accurate and economic reverse phase liquid chromatographic method was developed for the estimation of Sofosbuvir in all polymorphic form. Mobile phase contain acetonitrile and 0.05M ammonium acetate (pH 7.6) in ratio of 50:50 (v/v). A logarithmic calibration curve was plotted from 10 μg/mL to 60 μg/mL (r = 0.9989) for sofosbuvir, with the limit of detection (LOD) and the limit of quantification (LOQ) of 0.245 μg/mL and 0.816 μg/mL, respectively. The developed method was highly validated and practiced for the assurance of sofosbuvir raw materials with acceptable and non-objectionable accuracy and precision results (recovery 99–102%, RSD <1.2%, n = 3). Zero significant difference (t-test) was obtained between the overall results of the developed RP-HPLC method.
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来源期刊
CiteScore
1.10
自引率
16.70%
发文量
16
审稿时长
15 weeks
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