摘要
目的采用HPLC法测定盐酸伊立替康脂质体注射液中的溶血卵磷脂的含量。方法色谱柱采用C8柱;流动相为甲醇-0.1mol.L-1醋酸铵溶液(85∶15);柱温30℃,示差折光检测器。结果溶血卵磷脂浓度为0.1216～0.2838mg.mL-1与峰面积线性关系良好(r=0.9992)。结论方法简便,结果准确,盐酸伊立替康与溶血卵磷脂达到很好分离,适用于对盐酸伊立替康脂质体注射液中的溶血卵磷脂的质量控制。
Objective To establish a HPLC method for determination of myristoyl in Irinotecan Hydrochloride Liposome Injection. Methods Using a C4 column, the mobile phase consisted of methanol-0. 1mol·L^-1ammonium acetate （85 ： 15）, the column temperature was 30℃, differential refractive index detector was used. Results The calibration curve for myristoyl was liner between 0. 1216-0. 2838mg ·mL^-1 （r=0. 9992）. Conclusions This method is simple and accurate, irinotecan hydrochloride and myristoyl can be separated very well. It is suit for control of myristoyl in Irinotecan Hydrochloride Liposome Injection.
出处
《中国药事》
CAS
2009年第5期457-458,共2页
Chinese Pharmaceutical Affairs
