高效液相色谱法测定盐酸莫西沙星葡萄糖注射液中枸橼酸钠含量

Determination of Sodium Citrate in Moxifloxacin Hydrochloride and Glucose Injection by HPLC

目的建立测定盐酸莫西沙星葡萄糖注射液中枸橼酸钠含量的高效液相色谱法。方法色谱柱为安捷伦Zorbax-SB C_(18)柱(250 mm×4.6 mm,5μm),流动相A为甲醇,流动相B为50 mmol/L磷酸二氢钾溶液(用磷酸调pH至2.2),梯度洗脱,流速为0.9 mL/min,检测波长为210 nm,进样量为20μL。结果枸橼酸钠质量浓度在0.07834~0.14198 mg/mL范围内与峰面积线性关系良好(r=0.998,n=6);平均加样回收率为100.24%,RSD为1.13%(n=9);重复性、中间精密度、稳定性试验的RSD均小于2.0%。3批样品中枸橼酸钠的含量分别为0.103,0.102,0.104 mg/mL(n=3)。结论该方法操作简便、结果准确、灵敏度高,可用于盐酸莫西沙星葡萄糖注射液中枸橼酸钠的含量测定。

Objective To establish a high-performance liquid chromatography(HPLC)method for the determination of sodium citrate in Moxifloxacin Hydrochloride and Glucose Injection.Methods The chromatographic column was Agilent Zorbax-SB C_(18) column(250 mm×4.6 mm,5μm),the mobile phase A was methanol,the mobile phase B was 50 mmol/L potassium dihydrogen phosphate solution(adjusted to pH 2.2 by phosphoric acid),the elution method was gradient elution,the flow rate was 0.9 mL/min,the detection wavelength was 210 nm,and the injection volume was 20μL.Results The linear range of sodium citrate was 0.07834-0.14198 mg/mL(r=0.998,n=6).The average recovery of sodium citrate was 100.24% with an RSD of 1.13%(n=9).The RSDs of repeatability,intermediate precision and stability tests were lower than 2.0%.The contents of sodium citrate in the three batches of samples were 0.103,0.102 and 0.104 mg/mL(n=3),respectively.Conclusion The method is simple,accurate and sensitive,which can be used for the determination of sodium citrate in Moxifloxacin Hydrochloride and Glucose Injection.