HPLC法用于氯唑西林钠胶囊溶出度的测定  

Determination of dissolution of cloxacillin sodium capsule by HPLC

作　　者：杨慧元[1] 乐健[1] 陈桂良[1] 

机构地区：[1]上海市药品检验所,上海200233

出　　处：《药学实践杂志》2004年第2期83-85,共3页Journal of Pharmaceutical Practice

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 C_(18)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。Objective: To establish a method for determine the dissolution of cloxacillin sodium capsule. Methods: Separations were performed on a Lichrospher C_(18) (octadecyl silicane) column, using 0.02mol/L KH_2PO_4 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.

关 键 词：HPLC法 氯唑西林钠胶囊 溶出度 测定 

分 类 号：R927[医药卫生—药学]