硝苯地平缓释片(Ⅰ)有关物质检查方法的改进

Improvement of Testing Method of Related Substances in Nifedipine Sustained-release Tablets (Ⅰ)

目的:改进硝苯地平缓释片(Ⅰ)有关物质的检查方法。方法:色谱条件与《国家药品标准》要求的一致,计算杂质含量时将标准中关于"其它杂质峰面积小于对照品溶液中硝苯地平峰面积10%忽略不计"改进为"其它杂质峰面积小于对照品溶液中硝苯地平峰面积2%忽略不计"。结果:杂质含量按国家药品标准和改进后方法测得结果分别为0.00%、0.08%、0.29%、0.14%和0.10%、0.21%、0.51%、0.27%。结论:改进后的检验方法可以严格控制各杂质含量,从而提高药品质量标准。

OBJECTIVE： To improve the testing method of the related substances in nifedipine sustained - release tablets （ Ⅰ ） . METHODS： The chromatographic condition was in line with the ＂State Drug Standard＂. In computing the contents of foreign substances, the standard of ＂it is negligible if the peak area of foreign substances was less than 10% of the peak area of Nifedipine in the standard solution＂ was improved to be ＂it is negligible if the peak area of foreign substances was less than 2% of the peak area of Nifedipine in the standard solution＂ . RESULTS： The contents of the foreign substances determined in accordance with the ＂National Drug Standard＂ weresignificantly different from those determined by the improved method （0.00% , 0.08% , 0.29% , 0.14 % vs. 0.10% , 0.21% , 0.51% , 0.27% , respectively） . CONCLUSION： The improved method can help improve the standard drug quality in that the contents of the foreign substances can be strictly kept under control.