富马酸卢帕他定胶囊的溶出度研究

目的:建立测定富马酸卢帕他定胶囊溶出度的方法。方法:以紫外分光光度法测定富马酸卢帕他定含量,测定波长为268nm;采用篮法,以0.1mol·L-1盐酸溶液作为溶出介质,转速为100r·min-1,对3批富马酸卢帕他定胶囊在5、10、15、20、30、45min内进行溶出度均一性和批间重现性试验。结果:富马酸卢帕他定检测浓度线性范围为3.99～19.95μg·mL-(1r=0.9999),平均回收率为99.8%(RSD=0.92%,n=9);3批样品在30min时累积溶出度均大于98%,RSD小于5%(n=6),即溶出度均一性和重现性良好。结论:建立的方法操作简便、结果准确、稳定性好,可作为富马酸卢帕他定胶囊溶出度的测定方法。

Study on the Dissolution Rate of Rupatadine Fumarate Capsules

OBJECTIVE： To establish a method for dissolution rate determination of Rupatadine fumarate capsules. METHODS： The content of rupatadine fumarate was determined by UV spectrometry with detection wavelength of 268 nm. Using 0.1 mol·L^-1 hydrochloric acid solution as solvent and rotating speed of 100 r·min^-1, the homogeneity of dissolution rate and batch-to-batch reproducibility of 3 batches of Rupatadine fumarate capsules were determined within 5, 10, 15, 20, 30, 45 min by rotating basket method. RESULTS： The linear range of rupatadine fumarate was 3.99-19.95μg.mL^-1（r=0.999 9） with an average recovery of 99.8% （RSD=0.92%, n=9）. The accumulative dissolution rates of 3 batches of samples at 30 min were all higher than 98% （RSD〈5%, n=6）. The homogeneity and reproducibility of dissolution rate were good. CONCLUSION： The method is simple, accurate, stable and suitable for dissolution determination of Rupatadine fumarate capsules.