对《中国药典》中复方乳酸钠葡萄糖注射液乳酸钠含量测定方法的探讨

Discussion on the Analytical Method of Sodium Lactate in Compound Sodium Lactate and Glucose Injection in Chinese Pharmacopoeia

目的探讨并建立复方乳酸钠葡萄糖注射液中乳酸钠含量的测定方法,为《中国药典》中复方乳酸钠葡萄糖注射液乳酸钠含量测定方法的修订提供参考。方法采用RP-HPLC测定复方乳酸钠葡萄糖注射液中乳酸钠的含量,并与药典法进行比较。采用Shim-pack VP-ODS C_(18)色谱柱(4.6 mm×250 mm,5μm),流动相为甲酸-二环己基胺-水(1:1:998,V/V),流速为1.0mL·min·(-1),检测波长为210 nm,柱温为40℃,进样量为20μL。结果在0.51~6.07 mg·mL^(-1)内线性关系良好(r=0.999 9)平均回收率为99.47%,RSD值为0.75%(n=9)。结论建立的RP-HPLC可准确测定该制剂中乳酸钠的含量,为修订《中国药典》中的乳酸钠含量测定方法提供依据。

OBJECTIVE To establish a RP-HPLC method for the determination of sodium lactate in compound sodium lactate and glucose injection and provide reference for revision of method recorded in Chinese Pharmacopoeia. METHODS The separation was performed on a Shim-pack VP-ODS C18 analytical column（4.6 mm×250 mm, 5 μm）, and the mobile phase was formic acid-dicyclohexylamine-water （1∶1∶998, V/V） at a flow rate of 1.0 mL·min^-1. The detection wavelength was set at 210 nm and the column temperature was maintained at 40 ℃. The loading volume was 20 μL. The RP-HPLC method and the cation exchange resin method adopted by Chinese Pharmacopoeia were both used to determine the content of sodium lactate in compound sodium lactate and glucose injection, and the RESULTS were compared. RESULTS The linear range of the RP-HPLC method was 0.51-6.07 mg·mL^-1（r=0.999 9）. The average recovery was 99.47% （RSD = 0.75%, n=9）. CONCLUSION The established method of RP-HPLC can be used for the determination of sodium lactate in compound sodium lactate and glucose injection.