柱后衍生化高效液相色谱法测定注射用硫酸阿米卡星___

摘要 目的：建立柱后衍生化高效液相色谱法测定硫酸阿米卡星含量的方法。方法：色谱柱为Waters SunFire C18（4.6 mm×150 mm，5 μm） 流动相为含戊烷磺酸钠和冰醋酸的硫酸钠溶液-甲醇（97∶3） 柱温25 ℃，流速1.0 mL•min-1。柱后衍生化试液为邻苯二甲醛溶液，流速0.5 mL•min-1，衍生化反应温度45 ℃，荧光激发波长360 nm，测定波长440 nm。结果：硫酸阿米卡星在2.09~41.81 mg•L-1浓度范围内线性关系良好（r=0.9999），平均回收率（n=9）为98.6%。结论：该方法简便快速，结果准确可靠，可用于注射用硫酸阿米卡星的含量测定。

Abstract Objective:To establish a method of HPLC with post-column derivatization for determination amikacin sulfate injection.Methods:A Waters SunFire C18 column（4.6 mm×150 mm，5 μm）was used，and the mobile phase was sodium sulfate solution (containing pentanesulfonate sodium salt and glacial acetic acid)-methanol (97∶3),column temperature was 25 ℃,at a flow rate of 1.0 mL•min-1.OPA solution was used for post-column derivatization online,at a flow rate of 0.5 mL•min-1.The temperature of post-column reaction was set at 45 ℃,detected by fluorescence detector (λex 360 nm,λem 440 nm).Results:The calibration curve was linear in the range of 2.09-41.81 mg•L-1 (r=0.9999).The average recovery（n=9） was 98.6%.Conclusion:The method presented in this study showed good accuracy,more precision,simplicity and reproducibility as a recommendable option for quality control of amikacin sulfate injection and its related substances.

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