高效液相色谱法测定复方替加氟胶囊含量及其溶出度  

Studies on dissolution of compound tegafur capsules by means of HPLC assay

作　　者：吴毅彦[1] 左文坚[1] 

机构地区：[1]天津市药品检验所,天津300070

出　　处：《中国药学杂志》2003年第7期534-537,共4页Chinese Pharmaceutical Journal

摘　　要：目的　建立一种高效液相色谱法测定复方替加氟胶囊含量及其溶出度。方法　采用Diamonsil C18柱 (5 μm ,4 .6mm×2 5 0mm) ,用冰醋酸调节甲醇 2mmol·L-1庚烷磺酸钠溶液 (10∶90 ) pH值至 3.5 0 ,抽滤后 ,每 10 0 0mL溶液加乙醚 2mL为流动相 ,流速为 1.0mL·min-1,UV检测波长为 2 80nm。结果　此方法线性关系良好 ,替加氟与尿嘧啶的平均回收率为10 0 .0 % ,10 0 .7% ,RSD为 0 .2 1% ,0 .98% (n =9)。结论　本方法简单、快速、结果准确可靠 ,为控制复方替加氟胶囊的质量提供了依据。OBJECTIVE: A HPLC method was established for the determination of tegafur and uracil in compound tegafur capsules and its dissolution. METHODS: The chromatographic condition was as following:Diamonsil C18 column (5 μm, 4.6 mm × 250 mm); methanol and 2 mmol&middotL-1 sodium sulphonate heptane solution (10:90, adjusted pH to 3.50 by acetic acid), with 2 mL diethyl ether to 1000 mL solution as the mobile phase. The flow rate was 1.0 mL&middotmin-1. The wavelength of detection was 280 nm. RESULTS: The mean recoveries of tegafur and uracil were 100.0% and 100.7% with RSD 0.21% and 0. 98% (n = 9) respectively. CONCLUSION: The proposed method appeared bo be simple, rapid, accurate and reliable.

关 键 词：高效液相色谱法 测定 复方替加氟胶囊 含量 溶出度 

分 类 号：R979.1[医药卫生—药品]