双嘧达莫2种定量分析方法的比较

目的:探讨高氯酸非水滴定法和高效液相色谱(HPLC)法测定双嘧达莫原料药含量的可行性。方法:非水滴定法采用电位法指示终点,并考察不同溶剂对滴定的影响;HPLC法中,色谱柱为C18,流动相为乙腈-20mmol·L-1磷酸二氢钾(含1.0%三乙胺,磷酸调pH至4.0)=35∶65;并与《中国药典》规定的溴酸钾滴定法进行比较。结果:非水滴定法、HPLC法和溴酸钾滴定法的含量分别为101.36%、101.11%、100.56%。结论:高氯酸非水滴定法和HPLC法均可用于双嘧达莫原料药的含量测定,且高氯酸非水滴定法操作更简便、快捷。

Comparison of 2 Kinds of Quantitative Analytical Methods on Dipyridamole

OBJECTIVE： To validate the feasibility of nonaqueous perchloric acid titration and high performance liquid chromatography （HPLC） for the determination of the content of dipyridamole. METHODS： In the nonaqueous titration, the titration end- point was indicated potentiometrically, and the effects of different, solvents on the titration were investigated. As to HPLC method, the separation of sample was performed on C18 column with the mobile phase consisted of acetonitrile - 20 mmol · L^-1 potassium dihydrogen phosphate （containing 1.0% triethylamine, adjusted pH to 4.0 with phosphoric acid, 35 ： 65）. The potassium bromate titration stated in Chinese Pharmacopoeia was taken as the reference. RESULTS： By nonaqueous titration, HPLC and potassium bromate method, the contents of dipyridamole were 101.36%, 101.11% and 100.56%, respectively. CONCLUSIONS： Both nonaqueous titration and HPLC methods are suitable for the determination of the content of dipyridamole in its pharmaceutical products. Compared with potassium bromate titration, nonaqueous titration is more simple and convenient.