复方右旋糖酐40注射液中乳酸钠含量测定方法的改进

Improvement of the contents determination method for sodium lactate in Compound Dextran 40 Injection

目的改进复方右旋糖酐40注射液中乳酸钠的含量测定方法。方法采用HPLC法,色谱柱:ODS(250mm×4.6mm,5μm);流动相:1mL·L-1磷酸水溶液;流速:1.0mL·min-1;检测波长:210nm。结果乳酸钠质量浓度的线性范围为0.104 1～5.205mg·mL-1,相关系数为0.999 8,回收率为100.9%(n=9),RSD为0.6%。结论该方法简便,结果准确,重复性好,可作为控制复方右旋糖酐40注射液中乳酸钠的含量测定方法。

Objective To improve the contents determination method of sodium lactate in Compound Dextran 40 Injection. Methods The contents of sodium lactate were measured by HPLC with an ODS chromatographic column （250 mm×4. 6 mm, 5 μm）. 1 mL· L-l aqueous solution of phosphoric acid was used as the mobile phase at flow rate 1.0 mL · min-1. The detection wave-length was 210 nm. Results The caliberation curves showed good linearity in the range of 0. 104 1-5. 205 mg·mL-1 and the corre-lation coefficient was 0. 999 8. The average recovery was 100.9 % （n= 9 ） with RSD 0.6%. Conclusion The established method is accurate and reproducible,and can be used for the quality control of sodium lactate in Compound Dextran 40 Injection.