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Assay of sertraline in tablets and drug substance by liquid chromatography.

机译:液相色谱法测定片剂和原料药中舍曲林的含量。

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摘要

A high-performance liquid chromatography isocratic procedure was developed for the assay of sertraline in drug substance and tablets. The chromatographic system consists of a RP-8 column (125 x 4 mm, 5 microm), a mobile phase composed of acetonitrile and sodium phosphate buffer, pH 5.5 (7:3), flow rate of 1.0 ml.min(-1) and UV detection at 270 nm. The method validation yielded good results. The coefficient of variation varied between 0.19 and 1.04% and accuracy of 99.18% was found. Calibration curve was linear between 0.5 and 2.5 mg x ml(-1); its correlation coefficient was 0.9999.
机译:开发了一种高效液相色谱等度方法,用于测定原料药和片剂中的舍曲林。色谱系统由RP-8色谱柱(125 x 4 mm,5微米),由乙腈和磷酸钠缓冲液组成的流动相,pH 5.5(7:3),流速为1.0 ml.min(-1)组成在270 nm处进行紫外检测。方法验证产生了良好的结果。变异系数在0.19%至1.04%之间变化,准确度为99.18%。校准曲线在0.5至2.5 mg x ml(-1)之间呈线性关系;相关系数为0.9999。

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