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采用毛细管电泳-电容耦合非接触式电导检测法测定药物中环吡酮胺的含量。

Determination of ciclopirox olamine in pharmaceutical products by capillary electrophoresis with capacitively coupled contactless conductivity detection.

机构信息

Instituto de Química, Universidade de São Paulo, São Paulo, SP, Brazil.

出版信息

Electrophoresis. 2011 Apr;32(8):900-5. doi: 10.1002/elps.201000612. Epub 2011 Mar 11.

Abstract

This paper describes the determination of ciclopirox olamine in pharmaceutical formulations using capillary electrophoresis with capacitively coupled contactless conductivity detection. In an alkaline medium, ciclopirox olamine is converted into an anionic species and its detection is possible in capillary electrophoresis with capacitively coupled contactless conductivity detection without an electroosmotic flow modifier, because it is a low-mobility species. A linear working range from 2.64 to 264 μg/mL in sodium hydroxide electrolyte as well as low detection limit (0.39 μg/mL) and a good repeatability (RSD = 3.4% for 264 μg/mL ciclopirox solution (n = 10)) were achieved. It was also possible to determine olamine in its cationic form when acetic acid was used as the electrolyte solution. The results obtained include a linear range from 26.4 to 184.8 μg/mL and a detection limit of 2.6 μg/mL olamine. The proposed methods were applied to the analysis of commercial pharmaceutical products and the results were compared with the values indicated by the manufacturer as well as those obtained using a titrimetric method recommended by American Pharmacopoeia.

摘要

本文描述了使用毛细管电泳-电容耦合非接触式电导检测法测定药物制剂中环吡酮胺的含量。在碱性介质中,环吡酮胺转化为阴离子形式,在没有电渗流改性剂的情况下,使用毛细管电泳-电容耦合非接触式电导检测法即可对其进行检测,因为它是一种低迁移率的物质。在氢氧化钠电解质中,线性工作范围为 2.64 至 264μg/mL,检测限低(0.39μg/mL),重复性好(264μg/mL 环吡酮溶液(n=10)的 RSD=3.4%)。当使用乙酸作为电解质溶液时,也可以测定其阳离子形式的环吡酮胺。得到的结果包括线性范围为 26.4 至 184.8μg/mL 和检测限为 2.6μg/mL 环吡酮胺。所提出的方法用于分析商业药物产品,并将结果与制造商指示的值以及美国药典推荐的滴定法获得的值进行比较。

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