高效液相色谱法测定枸橼酸莫沙必利片及分散片溶出度

统一枸橼酸莫沙必利溶出度方法为桨法,以盐酸溶液(9→1000)900 ml为溶出介质,转速为50 r/min；检测方法由原来的紫外分光光度法改为高效液相色谱法,色谱柱为 C18,流动相为0.01 mol/ml 磷酸氢二钠溶液(0．1%三乙胺,用磷酸调节pH至3.5)-乙腈(75∶25),检测波长为220 nm,进样量为20μl。枸橼酸莫沙必利在2.0150~10.0750μg/ml范围内符合线性方程Y=73791.033X+7506.299(r=0.9999),平均回收率为100.5%(RSD为0.6%)。

HPLC Method in Detection of Dissolution Rates of Mosapride Citrate Tablets and Dispersible Tablets

The uniform method for Mosapride Citrate dissolution experiment was paddle method, and hydrochlo-ric acid solution (9→1000) 900 ml was used as solvent with 50 r/min rotating speed. The detective method changed from ultraviolet spectrophotometry ( UV) to high performance liquid chromatography ( HPLC) . The chromatographic col-umn was C18 column;mobile phase was composed of 0. 01 mol/ml sodium hydrogen phosphate solution (0. 01% triethyl-amine adjusted with phosphoric acid to pH 3. 5)-acetonitrile (75:25);detective wavelength was set at 220 nm, and the injection volume was 20 μl. Linear equation was Y=73 791. 033X+7 506. 299 (r=0. 9 999) when Mosapride Citrate within range of 2. 0 150-10. 0 750 μg/ml, and average recovery rate was 100. 5% (RSD=0. 6%).