HPLC外标法测定左炔诺孕酮炔雌醚片含量  

Determination of content of levonorgestrel and quinestrol tablets by HPLC

作　　者：简淑娟[1] 

机构地区：[1]广东省惠州市药品检验所,516001

出　　处：《中国现代药物应用》2009年第2期43-44,共2页Chinese Journal of Modern Drug Application

摘　　要：目的建立外标法测定左炔诺孕酮炔雌醚片含量的方法。方法采用HPLC外标法,以C18柱(150mm×5mm,5μm)为固定相,乙腈-水(80:20)为流动相,检测波长为220nm。结果左炔诺孕酮在0.2418～2.4175μg(r=0.9999)范围内线性关系良好,平均回收率为98.8%,RSD为1.0%(n=9);炔雌醚在0.1232～1.2316μg(r=1.000)范围内线性关系良好,平均回收率为99.2%,RSD为1.1%(n=9)。结论本方法简便准确,重复性好,可用于控制其内在质量。Objective To establish a HPLC method for determination of content of Levonorgestrel and Quinestrol Tablets. Method C18 column （ 150 mm × 5 mm, 5 μm）was used with a mobile phase of acetonitrilewater（80：20）. The content was detected at wavelength of 220 nm. Result The Levonorgestrel calibration curves were linear in the range of 0. 2418 - 2. 4175 μg（ r = 0. 9999 ）. The average recovery was 98.8% with RSD 1.0% （ n = 9 ）. The Quinestrol calibration curves were linear in the range of 0. 1232 - 1. 2316 μg（ r = 1. 000）. The average recovery was 99. 2% with RSD 1.1% （n =9）. Conclusion The method is simple,realizable and reproducible and can be effectively used for quality control of Levonorgestrel and Quinestrol Tablets.

关 键 词：左炔诺孕酮炔雌醚片 外标法 含量 

分 类 号：R927.2[医药卫生—药学] R169.41