Improvement of the Determination Method of Content and Related Substances of Molsidomine Tablet
10.6039/j.issn.1001-0408.2016.12.30
- VernacularTitle:吗多明片的含量及有关物质测定方法改进
- Author:
Shuqin HAN
;
Xiaojie BAI
- Publication Type:Journal Article
- Keywords:
Molsidomine tablet;
HPLC;
MS;
Content;
Related substance
- From:
China Pharmacy
2016;27(12):1674-1677
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To improve the method for the determination of content and related substances of Molsidomine tablet. METHODS:HPLC was adopted to determine the content and related substances,HPLC-MS was adopted for the qualitative degra-dation impurities in destruction test. The column was Waters Symmetry-C18 with mobile phase of 0.05% formic acid- methanol (gradient elution) at a flow rate 1.0 ml/min and 0.2 ml/min (respectively for content and related substances determination,mass spectrometry),the detection wavelength was 210 nm,column temperature was 30℃,the injection volume was 20μl and 5μl(re-spectively for content and related substances determination,mass spectrometry). RESULTS:Each component was well separated un-der chromatographic conditions;degradation impurities were confirmed;the linear range of molsidomine was 4. 0-28.0 μg/ml(r=0.9997);RSDs of precision,stability and reproducibility tests were lower than 1%;recovery was 97.74%-100.70%(RSD=0.49%,n=9). CONCLUSIONS:The method is simple,accurate with good specific and high precision,and can improve the quali-ty control of Molsidomine tablet.
