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高效液相色谱法(CE)与液相色谱法(LC)用于同时测定注射用制剂中阿莫西林/克拉维酸和氨苄西林/舒巴坦的含量

CE versus LC for simultaneous determination of amoxicillin/clavulanic acid and ampicillin/sulbactam in pharmaceutical formulations for injections.

作者信息

Pajchel Genowefa, Pawłowski Krzysztof, Tyski Stefan

机构信息

Antibiotics and Microbiology Department, Drug Institute, 30/34 Chełmska St., 00-725 Warsaw, Poland.

出版信息

J Pharm Biomed Anal. 2002 Jun 20;29(1-2):75-81. doi: 10.1016/s0731-7085(02)00029-8.

Abstract

A rapid, capillary electrophoresis method was evaluated for determination of amoxicillin and clavulanic acid in Augmentin as well as ampicillin and sulbactam in Unasyn preparations for injections. Phosphate-borate buffer at pH 8.66 containing 14.4% sodium dodecyl sulfate was used as a mobile phase. The method was validated. Reproducibility, precision, accuracy and assay linearity in concentration of amoxicillin 0.05-3.03 mg/ml and ampicillin 0.05-3.08 mg/ml, as well as clavulanic acid 0.02-2.02 mg/ml and sulbactam 0.05-2.08 mg/ml were established. This new method is fast, inexpensive and limits consumption of organic solvents when compared with alternative high performance liquid chromatography (HPLC) method, used for drug analysis. Statistical analysis by Student's t-test showed no significant differences between the results obtained by the two methods t(calculated) 0.32 and 1.69 for amoxicillin and clavulanic acid and 0.67 and 1.93 for ampicillin and sulbactam were smaller than t(tabulated).

摘要

评价了一种快速毛细管电泳法,用于测定奥格门汀中的阿莫西林和克拉维酸以及优立新注射剂中的氨苄西林和舒巴坦。使用含14.4%十二烷基硫酸钠的pH 8.66磷酸盐-硼酸盐缓冲液作为流动相。该方法经过验证。确定了阿莫西林浓度在0.05 - 3.03 mg/ml、氨苄西林浓度在0.05 - 3.08 mg/ml、克拉维酸浓度在0.02 - 2.02 mg/ml以及舒巴坦浓度在0.05 - 2.08 mg/ml时的重现性、精密度、准确度和测定线性。与用于药物分析且可供选择的高效液相色谱(HPLC)方法相比,这种新方法快速、成本低且有机溶剂消耗量少。通过学生t检验进行的统计分析表明,两种方法所得结果之间无显著差异,阿莫西林和克拉维酸的t(计算值)分别为0.32和1.69,氨苄西林和舒巴坦的t(计算值)分别为0.67和1.93,均小于t(表格值)。

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