HPLC法测定乳酸左氧氟沙星氯化钠注射液中的依地酸二钠

Determination of disodium edetate in levofloxacin lactate and sodium chloride injection by HPLC

目的 建立乳酸左氧氟沙星氯化钠注射用中依地酸二钠的测定方法。方法 样液中依地酸二钠经氯化铁衍生化后用HPLC检测。考察了离子对试剂浓度、磷酸盐浓度、水相pH、有机相比例以及衍生化试剂用量等对测定的影响。结果 优化的色谱条件为:C;色谱柱,流动相:50 mmol/L磷酸二氢钠溶液(含5 mmol/L的四丁基溴化铵,用磷酸溶液调节pH值至4.5)-乙腈(90:10,V/V);流速:1.0 mL/min;检测波长:257 nm。该方法分析时间仅需10 min。结论 本方法前处理简单快速,具有较好的准确度、灵敏度和精密度,适用于乳酸左氧氟沙星氯化钠注射用中依地酸二钠的质量控制。

Objective A method for the determination of disodium edetate in levofloxacin lactate and sodium chloride injection was established. Methods The disodium edetate in the sample solution was derivatized with ferric chloride and then detected by HPLC. The influence factors were investigated, such as the ion pair reagent concentration, the phosphate concentration, the aqueous pH, the organic phase ratio, and the amount of derivatization reagent. Results The optimized chromatographic condition was obtained when the mobile phase consisted of 50mmol/L sodium dihydrogen phosphate solution(containing 5 mmol/L tetrabutylammonium bromide, adjust the pH to 4.5 with phosphoric acid solution)-acetonitrile(90:10, V/V) at the flow rate of 1.0 mL/min with C;column.The detection wavelength was 257 nm. The analysis time of this method was only 10 minutes. Conclusion The pretreatment of this method is simple and fast. The method has good accuracy, sensitivity, and precision. This method can be used for the quality control of edetate in levofloxacin lactate sodium chloride injection.