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机构地区:[1]山东省青岛市药品检验所,青岛266071 [2]青岛双鲸药业有限公司
出 处:《中国药事》2008年第11期994-996,1001,共4页Chinese Pharmaceutical Affairs
摘 要:建立用高效液相色谱法测定盐酸班布特罗胶囊含量及其有关物质的方法。色谱柱为资生堂Capceupak C18柱,流动相为乙腈-磷酸盐缓冲液(0.02%庚烷磺酸钠,0.025mol.L^-1磷酸氢二铵,磷酸调pH值至5.4)(25∶75),流速1.0mL.min^-1,检测波长为220nm。盐酸班布特罗在10-130μg.mL^-1的范围内线性关系良好,r=1.000,平均回收率为100.5%,RSD为100.5%;各杂质峰和主峰分离良好。方法简便、准确、专属,适用于盐酸班布特罗胶囊的质量控制。T A HPLC method for determination of Bambuterol Hydrochloride and its related substances in Bambuterol Hydrochloride Capsules was established. Mobile phase was acetonitrile-phosphate buffer (pHS. 4) (25 : 75), and wavelength of detection was 220nm. In this condition there was a good linear relationship over the concentration range of 104130 μg · mL^-1 for bambuterol hydrochloride (r= 1. 000). The average recovery was 100. 5% . The detection chromatographic peaks of bambuterol hydrochloride method is simple and accurate. It can be applied to Capsules. limit of bambuterol hydrochloride was 9.0ng. The and its related substances were well isolated. This the determination of the Bambuterol Hydrochloride
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