Improvement of Testing Method of Related Substances in Nifedipine Sustained-release Tablets (Ⅰ)
- VernacularTitle:硝苯地平缓释片(Ⅰ)有关物质检查方法的改进
- Author:
Juan LI
;
Li WANG
;
Yu AN
- Publication Type:Journal Article
- Keywords:
Nifedipine sustained-release tablets(Ⅰ);
Related substances;
Improvement
- From:
China Pharmacy
2005;0(22):-
- CountryChina
- Language:Chinese
-
Abstract:
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.
