高效液相色谱法测定盐酸舒托必利注射液中的有关物质

Study on the Testing of Related Substances in Sultopride Hydrochloride Injection by HPLC

建立盐酸舒托必利注射液中的有关物质的检测方法。采用高效液相色谱法,以ODS-C18为固定相,乙腈-0.38%己烷磺酸钠的0.05%醋酸钠溶液(用醋酸调节pH=4.5)(20∶80)为流动相。能够有效分离有关物质,控制总杂质不超过1.5%。本方法准确、简便,适用于盐酸舒托必利注射液中的有关物质的检查。

A HPLC method for the testing of related substances in sultopride hydrochloride was established. An ODS-C18 column was used with acetonitrile and 0.05 % sodium acetate solution of 0. 38% sodium-hexanesulfonate （pH was adjusted to 4. 5 with acetic acid） （20 ： 80） as mobile phase. The related substance could be separated effectively and tested. The total amount of related substances was controlled no more than 1.5%. The method was accurate and simplified. It could be used for impurity control of sultopride hydrochloride.