药学研究2017，Vol.36Issue(6)：322-326,5.DOI:10.13506/j.cnki.jpr.2017.06.004
HPLC法测定罗氟司特片中的有关物质
Determination of related substances in Roflumilast Tablets by HPLC method
刘婷 1张露勇 1刘师卜 1张斗胜1
作者信息
- 1. 中国食品药品检定研究院,北京 100050
- 折叠
摘要
Abstract
Objective To establish a method for the determination of related substances in Roflumilast Tablets by HPLC method.Methods A Zorbax SB-C18 (4.6 mm×150 mm,5 μm)column was adopted,the mobile phase was consisted of 0.005 mol·L-1potassium dihydrogen phosphate-acetonitrile with gradient elution at a flow rate of 1.0 mL·min-1,and the detection wavelength was 250 nm.Results In the appropriate concentration range,roflumilast and the impurities peak area showed a good linear relationship with the concentration,the correlation coefficients were greater than 0.999.Conclusion The method was rapid,sensitive,accurate,and suitable for the determination of related substances in Roflumilast Tablets.关键词
罗氟司特/片剂/有关物质/高效液相色谱法Key words
Roflumilast/Tablets/Related substances/HPLC分类
医药卫生引用本文复制引用
刘婷,张露勇,刘师卜,张斗胜..HPLC法测定罗氟司特片中的有关物质[J].药学研究,2017,36(6):322-326,5.
