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作 者:殷果[1,2] 李慧义[3] 闫研[1,2] 宋茜[1,2,4] 丁振浩[1,2] 谭渺 江坤[1,2] 王铁杰[1,2]
机构地区:[1]深圳市药品检验所,深圳518057 [2]深圳药品质量标准研究重点实验室,深圳518057 [3]国家药典委员会,北京100061 [4]沈阳药科大学,沈阳110016
出 处:《药物分析杂志》2014年第2期368-371,共4页Chinese Journal of Pharmaceutical Analysis
基 金:全球基金项目国家药品标准提高(GF2012-40)
摘 要:目的:采用HPLC法建立青蒿素哌喹片中青蒿素溶出度测定方法。方法:采用桨法,以含0.5%十二烷基硫酸钠的磷酸盐缓冲液为溶出介质,转速为75 r·min^-1,45 min取样。采用Shim-pack VP-C18(150 mm×0.46 mm,5 μm)色谱柱,以乙腈-水(50:50)为流动相,柱温为30 ℃,流速为1.0 mL·min^-1,检测波长为210 nm。结果:青蒿素浓度在0.025-0.5 mg·mL^-1范围内线性关系良好(r=0.9996),平均回收率(n=9)为100.1%。3批样品在45 min的溶出度均超过标示量的70%。结论:本方法准确、可靠,灵敏度高,适用于青蒿素哌喹片中青蒿素溶出度的检测。Objective: To establish a method for the dissolution determination of artemisinin in artemisinin and piperaquine tablets by HPLC. Methods: The paddle method was adopted,using 500 mL of 0.5% sodium dodecyl sulfate solution in phosphate BS (pH 6.8) as solvent,the rotation speed at 75 r·min^-1.The chromatographic condition was as follows:the Shim-pack VP-C18(150 mm×0.46 mm,5 μm)column was used,the mobile phase was composed of acetonitrile-water (50:50) at the flow rate of 1.0 mL·min^-1,the detection wavelength was 210 nm and the column temperature was 30 ℃. Results: The calibration curve showed a good linearity in the range of 0.025-0.5 mg·mL^-1(r=0.9996).The average recovery (n=9) was 100.1%.Three batches of samples were detected using this method and the dissolution results were above 70% at 45 min. Conclusion: The method is accurate,reliable and sensitive,and can be applied to the dissolution determination of artemisinin in artemisinin and piperaquine tablets.
关 键 词:抗疟药 青蒿素哌喹片 溶出度 桨法 高效液相色谱法
分 类 号:R917[医药卫生—药物分析学]
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