胶束电动色谱法在口服药物制剂中舒他西林测定中的应用。

Application of micellar electrokinetic chromatography to the determination of sultamicillin in oral pharmaceutical preparations.

作者信息

Pajchel Genowefa, 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 Chromatogr A. 2002 Dec 6;979(1-2):315-21. doi: 10.1016/s0021-9673(02)01265-7.

DOI:10.1016/s0021-9673(02)01265-7

PMID:12498263

Abstract

A micellar electrokinetic capillary electrophoretic method for determination of sultamicillin in Unasyn oral preparations--tablets and suspension--was evaluated. Phosphate-borate buffer at pH 7.0 containing 1.0% sodium dodecylsulfate was used as a mobile phase. The elaborated method ensures separation of sultamicillin from p-toluenesulfonic acid and the impurities, ampicillin, sulbactam and penicillamine. The method was validated for specificity, reproducibility, precision, accuracy and assay linearity (in a concentration range of sultamicillin of 0.05-1.5 mg/ml). Statistical analysis by Student's t-test showed no significant differences between the results obtained by micellar electrokinetic chromatography and HPLC, t(calculated) 0.519 for suspension assays and 0.284 for tablets assays were smaller then t(tabulated).

摘要

评估了一种胶束电动毛细管电泳法用于测定优立新口服制剂（片剂和混悬剂）中的舒他西林。使用含1.0%十二烷基硫酸钠的pH 7.0磷酸盐-硼酸盐缓冲液作为流动相。所建立的方法可确保舒他西林与对甲苯磺酸以及杂质氨苄西林、舒巴坦和青霉胺分离。该方法在特异性、重现性、精密度、准确度和测定线性（舒他西林浓度范围为0.05 - 1.5 mg/ml）方面得到验证。通过学生t检验进行的统计分析表明，胶束电动色谱法和高效液相色谱法所得结果之间无显著差异，混悬剂测定的t（计算值）为0.519，片剂测定的t（计算值）为0.284，均小于t（表列值）。