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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 explore and establish a method for the determination of sodium lactate in compound sodium lactate dextrose injection and provide a reference for the revision of the method for determination of sodium lactate content in compound sodium lactate dextrose injection in Chinese Pharmacopoeia. Methods The content of sodium lactate in compound sodium lactate and glucose injection was determined by RP-HPLC and compared with the pharmacopoeia. The mobile phase consisted of acid-dicyclohexylamine-water (1: 1: 998, V / V) and the mobile phase was 1.0 mL with a Shim-pack VP-ODS C 18 column (4.6 mm × 250 mm, · Min · (-1), the detection wavelength was 210 nm, the column temperature was 40 ℃ and the injection volume was 20μL. The results showed good linearity (r = 0.999 9) in the range of 0.51 ~ 6.07 mg · mL -1 with an average recovery of 99.47% and RSD of 0.75% (n = 9). Conclusion The established RP-HPLC can accurately determine the content of sodium lactate in this preparation and provide the basis for revising the method of determination of sodium lactate content in “Chinese Pharmacopoeia”.