高效液相色谱法测定盐酸伊立替康注射液的含量

目的建立测定盐酸伊立替康注射液中盐酸伊立替康含量的高效液相色谱法。方法采用Agilent HC-C_（18）柱（250 mm×4.6 mm,5μm）,以磷酸盐缓冲液（称取无水磷酸二氢钠2.43 g和辛烷磺酸钠1.66 g,溶于1 000 mL水中）-甲醇-乙腈（57：25：18）为流动相,柱温为40℃,流速为1.5 mL/min,检测波长为255 nm。结果盐酸伊立替康质量浓度在0.1831~1.464 7 g/L范围内与峰面积呈良好线性关系（r=0.9994,n=7）,平均回收率为100.33%,RSD=0.46%（n=9）。结论该法准确、简便、重复性好,可用于盐酸伊立替康注射液的含量测定。

Content Determination of Irinotecan Hydrochloride Injection by HPLC

Objective To establish a high performance liquid chromatography（HPLC） method for the content determination of Irinotecan Hydrochloride Injection. Methods The HPLC method was performed on the Agilent HC- C18 column（250 mm ×4. 6 mm, 5 μm） with the mobile phase of phosphate buffer （dissolving anhydrous sodium dihydrogen phosphate 2.43 g and 1-octanesulfonic acid sodium 1.66 g in 1 000 mL of water）-methanol-acetonitrile （57：25：18）. The column temperature was 40℃, the flow rate was 1.5 mL/min and the detective wavelength was 255 nm. Results The linear range of irinotecan hydrochloride was 0. 183 1- 1. 464 7 mg/mL（r=0. 999 4, n =7）, the average recovery rate was 100. 33%, RSD was 0.46% （n =9）. Conclusion The method is accurate and simple with good repeatability, which can be used for the content determination of Irinotecan Hydrochloride Injection.