摘要
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。
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.
出处
《中国药房》
CAS
CSCD
北大核心
2011年第13期1205-1207,共3页
China Pharmacy
关键词
富马酸卢帕他定
胶囊
溶出度
紫外分光光度法
篮法
Rupatadine fumarate
Capsule
Dissolution rate
UV spectrometry
Rotating basket method
