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用于分析原料药和口服混悬剂中盐酸头孢他美酯的液相色谱法。

LC method for the analysis of cefetamet pivoxil hydrochloride in drug substance and powder for oral suspension.

作者信息

Morsch Lisoni M, Bittencourt Celso F, e Souza Marinês J, Milano Julie

机构信息

Programa de Pós-Graduação em Ciência e Tecnologia Farmacêuticas, Rua Capitão Fernando Tatsch, 881 apto 01, RS/CEP 96810.040, Santa Cruz do Sul, Brazil.

出版信息

J Pharm Biomed Anal. 2002 Oct 15;30(3):643-49. doi: 10.1016/s0731-7085(02)00343-6.

Abstract

A high-performance liquid chromatography isocratic procedure was developed for the assay of cefetamet pivoxil hydrochloride in drug substance and powder for oral suspension. The method validation yielded good results and included the range, linearity, precision intra- inter-day, accuracy, specificity, LOD and LOQ values. The chromatographic system consisted of a C(18) absorbosphere column (150 x 4.6 mm i.d., 5 microm particle size), a mobile phase composed of water-acetonitrile-methanol-phosphate buffer, pH 3.5 (50:35:10:5, v/v), flow rate of 1.5 ml min(-1) and UV detection at 254 nm. The relative standard deviation varied between 0.03 and 1.76%, and accuracy of 100.09% was found. Calibration curve was linear from 30.0-80.0 microg ml(-1); its correlation coefficient was 0.99989.

摘要

建立了一种高效液相色谱等度洗脱方法,用于测定原料药和口服混悬剂中盐酸头孢他美酯的含量。该方法验证结果良好,包括范围、线性、日内和日间精密度、准确度、专属性、检测限和定量限数值。色谱系统由一根C(18) 吸附球柱(内径150×4.6 mm,粒径5μm)、一种由水-乙腈-甲醇-磷酸盐缓冲液(pH 3.5,50:35:10:5,v/v)组成的流动相、流速为1.5 ml min(-1) 以及在254 nm处进行紫外检测组成。相对标准偏差在0.03%至1.76%之间变化,准确度为100.09%。校准曲线在30.0 - 80.0 μg ml(-1) 范围内呈线性;其相关系数为0.99989。

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