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创新微粒及市售制剂中抗生素万古霉素的毛细管电泳分析

Capillary electrophoretic analysis of the antibiotic vancomycin in innovative microparticles and in commercial formulations.

作者信息

Musenga A, Mandrioli R, Zecchi V, Luppi B, Fanali S, Raggi M A

机构信息

Faculty of Pharmacy, Department of Pharmaceutical Sciences, Alma Mater Studiorum-University of Bologna, Via Belmeloro 6, 40126 Bologna, Italy.

出版信息

J Pharm Biomed Anal. 2006 Sep 11;42(1):32-8. doi: 10.1016/j.jpba.2005.11.022. Epub 2005 Dec 27.

DOI:10.1016/j.jpba.2005.11.022
PMID:16378705
Abstract

A new fast capillary electrophoretic method has been developed for the analysis of the glycopeptide antibiotic vancomycin in formulations. An electrophoretic run is completed within 3.0 min; fused silica capillaries (100 microm i.d., 8.5 cm effective length and 48.5 cm total length) and a background electrolyte consisting of 12.5 mM, pH 2.5 phosphate buffer are used. The applied voltage is -20.0 kV; samples are injected by pressure (30 mbar x 3 s) at the anodic end of the capillary. The method was successfully applied to innovative controlled release microparticles consisting of a coated albumin core containing vancomycin. A simple procedure has been developed to obtain complete vancomycin extraction from microparticles using a 5% (w/v) sodium dodecyl sulphate aqueous solution. The method has been validated in terms of linearity, precision and accuracy. Good linearity was found in the 0.25-5.00 microg/mL range. Satisfactory precision was obtained, with relative standard deviation values always lower than 3.9%; accuracy was satisfactory, with recovery values between 97.8 and 102.2%. The method is also suitable for vancomycin determination in commercial capsules.

摘要

已开发出一种新的快速毛细管电泳方法,用于分析制剂中的糖肽类抗生素万古霉素。电泳运行在3.0分钟内完成;使用内径为100微米、有效长度为8.5厘米、总长度为48.5厘米的熔融石英毛细管,以及由12.5 mM、pH 2.5的磷酸盐缓冲液组成的背景电解质。施加电压为-20.0 kV;样品在毛细管阳极端通过压力(30 mbar×3 s)进样。该方法已成功应用于由含万古霉素的包衣白蛋白核组成的创新型控释微粒。已开发出一种简单的程序,使用5%(w/v)十二烷基硫酸钠水溶液从微粒中完全提取万古霉素。该方法已在线性、精密度和准确度方面得到验证。在0.25 - 5.00微克/毫升范围内发现良好的线性。获得了令人满意的精密度,相对标准偏差值始终低于3.9%;准确度令人满意,回收率在97.8%至102.2%之间。该方法也适用于商业胶囊中万古霉素的测定。

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