HPLC法用于氯唑西林钠胶囊溶出度的测定

杨慧元; 乐健; 陈桂良

HPLC法用于氯唑西林钠胶囊溶出度的测定

投稿时间：2003-08-21 点此下载全文

引用本文：杨慧元,乐健,陈桂良.HPLC法用于氯唑西林钠胶囊溶出度的测定[J].药学实践杂志,2004,(2):83~85

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作者	单位
杨慧元	上海市药品检验所, 上海 200233
乐健	上海市药品检验所, 上海 200233
陈桂良	上海市药品检验所, 上海 200233

中文摘要:目的建立了氯唑西林钠胶囊溶出度的HPLC测定方法。方法色谱条件:采用Lichrospher C₁₈柱(250mm×4.0mm,5μm),以0.02mool/L磷酸二氢钾(用氢氧化钠试液调节pH值为5.0)-乙腈(75:25)为流动相,检测波长225nm。结果氯唑西林钠在20.00～200.0μg/mL范围内呈良好线性,r=0.9999,平均加样回收率为100.4%(RSD=0.3%)。溶出度方法参照中国药典2000年版二部。本法排除了胶囊壳与辅料的干扰,数据准确合理。结论该法精密准确、简单可行,适用于氯唑西林钠胶囊体外溶出试验的质量控制。

中文关键词:氯唑西林钠胶囊高效液相色谱法溶出度

Determination of dissolution of cloxacillin sodium capsule by HPLC

Abstract:Objective To establish a method for determine the dissolution of cloxacillin sodium capsule. Methods Separations were performed on a Lichrospher C₁₈ (octadecyl silicane) column, using 0.02mol/L KH₂PO₄ solution(adjust to pH 5.0 with 8N sodium hydroxide)-aeetonitrile(75:25) as the mobile phase, the detection wavelength was 225nm. Result: The method showed the good linearity within the concentration range of 20.00～200.0μg/mL (r=0.9999 ) in assay. The average recovery was 100.4% (RSD=0.3%). The method of dissolution complies with Chinese pharmacopeia(Vol Ⅱ, 2000). Conclusion The method is accurate and simple, and suitable for the quality control of dissolution of cloxaeillin sodium capsule.

keywords:cloxacillin sodium HPLC dissolution

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