欧洲药典法测定非洛地平含量

目的建立非洛地平的含量测定方法。方法使用硫代硫酸钠标定的硫酸铈滴定液(0.1mol·L~(-1))对非洛地平含量进行测定,与《中国药典》中使用三氧化二砷标定的测定方法进行结果比较分析,这是该方法首次应用于非洛地平含量测定。结果在80%~120%范围内,校正体积与称样量呈良好线性关系,V=51.782 m+0.033 4(r=0.999 9)。2种方法测量值无显著性差异(P>0.05)。结论该方法简便、安全、快速、准确,适用于该产品的质量控制。

Content determination for felodipine by using European Pharmacopoeia method

Objective To establish a method for the content determination of felodipine .Methods Cerous sulfate standard solution de‐marcated by sodium thiosulfate was used to measure the content of felodipine ,and compared with the results obtained by the meth‐od of Ch .P .Results The titration volume and the drug ammount showed a good linear relationship in the range of 80%‐120% .The regression equation was V=51 .782 m+0 .033 4(r=0 .999 9) .There was no significant difference between the results obtained from the two methods(P>0 .05) .Conclusion The method is simple ,safe ,quick and accurate .It is suitable for the quality control of the product .