HPLC法测定盐酸伊立替康注射液的含量和有关物质

Determination of the Content and Related Substance of Irinotecan Hydrochloride Injection by HPLC

目的:建立盐酸伊立替康注射液含量及有关物质测定的方法。方法:采用高效液相色谱法,色谱柱为Hypersile Luna(2)C18,流动相为水溶液(含0.02mol/L磷酸二氢钠和0.008mol/L辛烷磺酸钠)-乙腈-甲醇(59∶17∶24,V/V/V),流速为1.5ml/min,检测波长为255nm,柱温为40℃。结果:盐酸伊立替康检测质量浓度线性范围为98.5～985.0μg/m(lr=0.99997),检测限为1.2ng;高、中、低3种浓度水平的平均回收率分别为99.4%、99.8%、99.6%(n=3),RSD分别为0.12%、0.10%、0.15%(n=3)。结论:建立的方法准确,适用于盐酸伊立替康制剂的质量控制。

OBJECTIVE： To establish the method for determination of the content and related substance of Irinotecan hydrochloride injection. METHODS： HPLC method was adopted. The determination was performed on Hypersile Luna （2） C18 column with mobile phase consisted of water （containing 0.02 mol/L sodium acid phosphate and 0.008 mol/L octanesulfonic acid sodium）-acetonitrile-methanol （59 ： 17 ： 24, V/V/V） at the flow rate of 1.5 ml/min. The detection wavelength was set at 255 nm, and the column temperature was controlled at 40 ℃. RESULTS： The linear range of irinotecan hydrochloride was 98.5-985.0 μg/ml （r=0.999 97） and the detection limit was 1.2 ng; average recovery rates of high, middle and low concentrations were 99.4%, 99.8% and 99.6% （n=3）, and RSDs were 0.12%, 0.10%, 0.15% （n=3）. CONCLUSIONS： The method is accurate, and it is suitable for the quality control of Irinotecan hydrochloride preparation.