HPLC-ELSD法测定硫酸妥布霉素注射液含量

Determination of tobramycin sulfate injection by HPLCELSD method

目的建立高效液相色谱-蒸发光散射检测（HPLC～ELSD）法测定硫酸妥布霉素注射液含量的方法。方法选择ZorbaxsB—C18色谱柱（250mm×4．6mm，5μm），以1％三氟醋酸水溶液-甲醇（90：10）为流动相，流速1ml／min；蒸发光散射检测器，漂移管温度40℃，载气压力3．5Bar。结果妥布霉素在0．4—1．6mg／ml的范围内呈较好的线性关系（r=0.9998），平均回收率99．8％，RSD=0．46％；系统精密度RSD=0．51％。结论方法操作简便、快速以及精密度、准确性、重现性均能很好地满足质量控制的要求，是一种比较理想的硫酸妥布霉素注射液含量测定分析方法。

Objective To establish an HPLC - performance liquid chromatograph （HPLC） - evaporative light - scattering detection （ELSD） method for determination of tobramycin sulfate. Methods The chromatography was performed on a column of Zorbax SB C 18（ （250mm × 4.6mm,5μm） . The mobile phase was 1% Trifluoroacetic - methanol（90： 10） withthe flow rate of 1ml· min^- 1, The drift tube temperature of 40 ℃ and ELSD was used as the detector with pressure of nebtdizing gas of 3.5 Bar. Results The linear calibration curve was in the range of 0.4 - 1.6mg· ml^-1, r = 0. 9998. The recovery was 99.8 %, RSD = 0. 46 %. The precision of the system was satisfactory （RSD = 0.51% ）. Conclusion It is a simple, rapid, accurate and reproducible method of quality control for determination the content of tobramycin sulfate injection.