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高效液相色谱法测定复方左炔诺孕酮片的含量
引用本文:霍慧珍,何作民.高效液相色谱法测定复方左炔诺孕酮片的含量[J].中国药业,2009,18(7):20-21.
作者姓名:霍慧珍  何作民
作者单位:广东省佛山市药品检验所,广东,佛山,528000
摘    要:目的建立测定复方左炔诺孕酮片中左炔诺孕酮和炔雌醇含量的高效液相色谱(HPLc)法。方法采用kromail ODS-1 C18色谱柱(200mm×4.6mm,5μm),流动相为乙腈-水(60:40),流速为1.0mL/min,检测波长为220nm,柱温为30℃,进样体积20uLo结果左炔诺孕酮质量浓度在0.7085~2.1255txg范围内与峰面积有良好线性关系(r=1.0000)平均回收率为101.28%,RSD为1.10%(n:6):炔雌醇质量浓度在0.1484~0.4452μg范围内与峰面积有良好线性关系(r=1.0000),平均回收率为99.92%,RSD为1.25%(n=6)。结论HPLC法简便、准确、专属性强、精密度高、重复性好。

关 键 词:高效液相色谱法  左炔诺孕酮  炔雌醇  含量测定

Determination of Main Component in Compound Levonorgestrel Tablet by HPLC
Huo Huizhen,He Zuomin.Determination of Main Component in Compound Levonorgestrel Tablet by HPLC[J].China Pharmaceuticals,2009,18(7):20-21.
Authors:Huo Huizhen  He Zuomin
Institution:(Foshan lnstitule for Drug Control, Foshan, Guangdong, China 528000)
Abstract:Objective To establish a HPLC method for the determination of levonogestrel and ethinylestradiol in Compound Levonorgestrel Tablets. Methods The chromatographic column: Kromail ODS-1 C18 column (200 mm×4.6 mm, 5μm).The mobile phase: acetonitrile- water(60:40). The flow rate was 1.0 mL/min, the wavelength was 220 nm. Results The linear range of levonogestrel was good within the range of 0. 708 5 -2. 125 5 μg ( r = 1. 000 0), the average recovery rate was 101.28%, RSD was 1.10% ( n =6); and that of ethinylestradiol was good within the range of 0. 148 4- 0. 445 2 μg (r=1.000 0), the average recovery rate was 99.92%, RSD was 1.25% (n =6). Conclusion The method is simple, accurate, stable and reliable for the determination of main compounds in Compound Levonorgestrel Tablets.
Keywords:HPLC  Levonogestrel  Ethinylestradiol  content determination
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