文章摘要
刘光敏.加校正因子的主成分自身对照法同时测定非那雄胺片中2个杂质[J].中国药品标准,2018,19(5):353-358
加校正因子的主成分自身对照法同时测定非那雄胺片中2个杂质
The Main Component self-Compare with Correction Factor Method for Determination of Related Substances in Finasteride TabletsLiu Guangmin (Zibo Vocational Institute, Shandong Zibo 255314)
投稿时间:2018-04-20  修订日期:2018-09-29
DOI:
中文关键词: 非那雄胺  有关物质  相对校正因子  高效液相色谱法
英文关键词: finasteride  related substance  relative correction factor  HPLC
基金项目:
作者单位E-mail
刘光敏* 淄博职业学院 gml1216@126.com 
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中文摘要:
      目的:建立加校正因子的主成分自身对照法测定非那雄胺片中有关物质的含量。方法:CAPCELL PAK C<sub>18</sub>色谱柱(4.6′250 mm,5 mm),流动相乙腈-水(45∶55),流速1.0 mL.min<sub>-1</sub>,检测波长210 nm,进样量20 mL,柱温30℃。测定非那雄胺与杂质Ⅰ、Ⅱ的标准曲线方程,以斜率计算杂质相对于非那雄胺的校正因子,用相对保留时间确定各杂质的位置。结果:非那雄胺杂质Ⅰ、Ⅱ的相对保留时间分别为0.85与1.30,相对校正因子分别为2.40与0.69。结论:本方法可用于非那雄胺片中有关物质的定性及定量分析,采用加校正因子的主成分自身对照法可以更准确的反映其有关物质的含量。
英文摘要:
      Objective: To establish the main component self-compare with correction factor method to determine the contents of related substances in finasteride tablets. Methods: An CAPCELL PAK C<sub>18 </sub>column(4.6′250 mm, 5 mm) was adopted with the mobile phase composed of acetonitrile-water (45∶55), at the flow rate of 1.0 mL.min<sub>-1</sub>. The detection was carried out at 210 nm, and a column temperature of 30 ℃. The injection volume was 20 mL. The slope of linear equation was used to determine the relative correction factor between impurity Ⅰ,Ⅱ and finasteride. The relative retention time was used to determine the position of impurities. Results: The relative retention time of impurity Ⅰ,Ⅱ was 0.85 and 1.30, respectively. The relative correction factor of impurity Ⅰ,Ⅱ was 2.40 and 0.69, respectively. Conclusion: The method can be used for the qualitative and quantitative analysis of the related substances in finasteride tablets, and the main component self-compare with correction factor method can reflect the content of related substances more accurately.
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