HPLC-ELSD法测定注射用硫酸异帕米星含量

Determination of isepamicin sulfate by HPLC-ELSD

目的建立高效液相色谱-蒸发光散射检测（HPLC-ELSD）法测定注射用硫酸异帕米星含量的方法。方法色谱柱为ZorbaxSB-C18色谱柱（250mm×4.6mm，5μm），流动相为1％三氟醋酸水溶液-甲醇（体积比95：5）），流速：0．5mL／min；蒸发光散射检测器，漂移管温度45℃，载气压力368Pa。结果异帕米星在0.1～0.8mg／mL的范围内呈较好的线性关系（r=0．9995），平均回收率101．0％，RSD=0．32％；系统精密度RSD=0.34％。结论本方法操作简便、快速，方法的精密度、准确性、重现性均较好地满足质量控制的要求，可用于注射用硫酸异帕米星的质量控制。

Objective To establish an HPLC-ELSD method for the quantification of isepamiein sulfate in the injection. Methods The analysis was performed on a column of Zorbax SB C18 （250 mm × 4.6 mm, 5 μm ）. The mobile phase consisted of 1% tifluoroaceticmethanol （95： 5）and the flow rate was 0. 5 mL · min^-1. The drift tube temperature was 45 ℃, ELSD was used as the detector with pressure of nebulizing gas of 368 Pa. Results The calibration curve was linear in the range of 0.1 - 0.7 mg/mL （ r = 0. 9995 ）. The average recovery was 101. 0% with RSD O. 32%. Conclusion This method is simple, rapid, accurate and reproducible for the quality control of the injection of isepamicin sulfate.