HPLC-ELSD法测定甲磺酸左氧氟沙星葡萄糖注射液中葡萄糖的含量

Content Determination of Glucose in Levofloxacin Mesylate/Glucose Injection by HPLC-ELSD

目的:建立以高效液相色谱-蒸发光散射检测法测定甲磺酸左氧氟沙星葡萄糖注射液中葡萄糖含量的方法。方法:色谱柱为Shim-pack VP-ODS,流动相为0.1mol·L-1醋酸铵溶液(用冰醋酸调节pH至4.0)-乙腈(梯度洗脱),流速为0.7mL·min-1,进样量为10μL;蒸发光散射检测器条件:氮气压力为35Psi,漂移管温度为80℃,喷雾器温度为48℃,衰减Gain值为10。结果:葡萄糖进样量的线性范围为49～148μg(r=0.999 8);平均回收率为100.18%(RSD=0.61%)。结论:该方法准确度高、专属性强,可用于该制剂中葡萄糖的含量测定。

OBJECTIVE： To establish an HPLC-ELSD method for the determination of glucose in levofloxacin mesylate/ glucose injeetion（LMG1）. METHODS： The samples were determined by HPLC- ELSD on shim- pack VP- ODS column using ammonium acetate solution （adjusted to pH4.0 with acetic acid glacial） aeetonitrile （gradient elution） as the mobile phase at a flow rate of 0.7 mL · min^-1. The injection volume was 10μL. The ELSD conditions were as follows： pressure of N2= 35 PSI; drift temperature = 80 ℃; spray temperature = 48 ℃ ; attenuation Gain = 10. RESULTS： The linear range of glucose was 49--148 μg （r = 0.999 8） and the average recovery rate was 100.18% （RSD = 0.61%） . CONCLUSIONS： The method is accurate, specific and applicable for the determination of glucose in LMGI.