琥珀酸西苯唑啉片溶出度的测定

Determination of the Dissolution of Cibenzoline Succinate Tablets by HPLC

目的:建立测定琥珀酸西苯唑啉片溶出度的方法。方法:采用高效液相色谱法按峰面积外标法测定及计算药物含量,色谱柱为Diamonsil C18,流动相为乙腈-磷酸(40∶60),检测波长为230nm;选用桨法测定溶出度。结果:琥珀酸西苯唑啉检测浓度线性范围为1～40μg·mL-1(r=0.9999);平均回收率为97.70%(RSD=0.14%);3批样品15min时溶出度均在80%以上。结论:所建立的溶出度测定方法简便、快捷,结果准确,可用于琥珀酸西苯唑啉片溶出度的测定。

OBJECTIVE： To establish a method for determination of the dissolution of cibenzoline succinate tablets. METHODS： The content of cibenzoline suceinate 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-phos-phoric acid（40 ： 60）.The detective wavelength was set at 230 nm. The dissolution was determined by paddle method. RE- SULTS： The linear range of cibenzoline succinate was 1-40μg·mL^-1（r = 0.9999） 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.