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采用液相色谱法测定片剂和原料药中的舍曲林。

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

作者信息

Adams A I, Bergold A M

机构信息

Curso de Pós-Graduação em Ciências Farmacêuticas, UFRGS, Av. Ipiranga, 2752, CEP 90610-000, Porto Alegre, Brazil.

出版信息

J Pharm Biomed Anal. 2001 Oct;26(3):505-8. doi: 10.1016/s0731-7085(01)00425-3.

DOI:10.1016/s0731-7085(01)00425-3
PMID:11489397
Abstract

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.

摘要

开发了一种高效液相色谱等度洗脱方法,用于原料药和片剂中舍曲林的含量测定。色谱系统由一根RP - 8柱(125×4 mm,5μm)、由乙腈和pH 5.5的磷酸钠缓冲液(7:3)组成的流动相、1.0 ml·min⁻¹的流速以及270 nm处的紫外检测组成。该方法验证取得了良好结果。变异系数在0.19%至1.04%之间,准确度为99.18%。校准曲线在0.5至2.5 mg·ml⁻¹之间呈线性;其相关系数为0.9999。

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