Determination of the Dissolution of Cibenzoline Succinate Tablets by HPLC / 中国药房

ABSTRACT

OBJECTIVE:To establish a method for determination of the dissolution of cibenzoline succinate tablets. METHODS: The content of cibenzoline succinate was determined by HPLC and computed based on the peak area in the external reference method. The chromatographic column was Diamonsil C18. The mobile phase consisted of acetonitrile-phosphoric acid(40∶60). The detective wavelength was set at 230 nm. The dissolution was determined by paddle method. RESULTS: The linear range of cibenzoline succinate was 1～40 ?g?mL-1(r=0.999 9) and the average recovery rate was 97.70%(RSD=0.14%).The dissolution rates of 3 batches of samples at 15 min were all above 80%.CONCLUSION: The established method is simple,rapid and accurate,and it is applicable for the determination of the dissolution of cibenzoline succinate tablets.