Content Determination and Dissolution Detection of Magnesium Valproate Tablets by GC Internal Standard Method / 中国药师

ABSTRACT

Objective: To establish a GC determination method for the content and dissolution of magnesium valproate tablets. Methods:Magnesium valproate tablets were detected by a GC internal standard method. The samples were dissolved in 0. 1 mol·L-1 hydrochloric acid solution, and then extracted by dichloromethane. Eicosane was used as the internal standard. The dissolution was de-termined by the first method described in ChP 2015 edition. The dissolution medium was 0. 1 mol·L-1 hydrochloric acid solution and the rotation speed was 100 r·min-1 with the sampling time at 45 min. The samples were extracted by dichiormethane, and eicosane was used as the internal standard as well. Results: The dissolution of magnesium valproate tablets showed good linearity within the range of 0. 005-1. 000 mg·ml-1(r=0. 9999). The recovery was 99. 2% (RSD=0. 5%, n=9). The dissolution curve showed that magnesium valproate released above 80% in 45 minutes. Conclusion:The method has good specificity and high accuracy, and can be used for the content determination and dissolution detection of magnesium valproate tablets.