A simple, rapid and cost-effective reverse phase high-performance liquid chromatographic (RP-HPLC) method was developed for the quantification of artesunate. C18 Promosil (ODS, 150 × 4.6 mm, 5 μm) column was used as stationary phase to separate the drug. Mobile phase comprised of ethanol: water (65:35) having pH 4.5 was run isocratically at a flow rate of 1 mL/min at 27°C. The method was validated according to ICH guidelines for linearity, precision, accuracy, robustness, specificity, limit of detection (LOD) and limit of quantification (LOQ). The method was found accurate, precise and robust with an average retention time of 4.509 min and 0.5357 %RSD. Good linearity was observed in the concentration range of 2–10 mg/ml with regression coefficient R2 value of 0.9995 and slope value of 369,928. Conclusively, as per ICH norms, the developed method was successfully validated and used for the quantification of artesunate in fast dissolving tablets (FDTs).

中文翻译：

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RP-HPLC法测定和定量青蒿琥酯。

开发了一种简单，快速且经济高效的反相高效液相色谱（RP-HPLC）方法用于青蒿琥酯的定量分析。使用C18 Promosil（ODS，150×4.6 mm，5μm）色谱柱作为固定相来分离药物。在27°C下以1mL / min的流速等度运行由pH为4.5的乙醇：水（65:35）组成的流动相。该方法已根据ICH指南验证了线性，精密度，准确性，鲁棒性，特异性，检测限（LOD）和定量限（LOQ）。发现该方法准确，精确和可靠，平均保留时间为4.509分钟，RSD为0.5357％。在2-10 mg / ml的浓度范围内观察到良好的线性，回归系数R2值为0.9995，斜率值为369,928。最后，按照ICH规范，