摘要
目的:建立能有效分离18α-、18β-甘草酸的HPLC方法并用于测定甘草酸二铵及其制剂的含量。方法:采用Agilent HC-C18(2)色谱柱(4.6 mm×250 mm,5μm);乙腈-磷酸盐缓冲液(pH7.0)(22∶78)为流动相;流速:1.0 mL.min-1;检测波长:250 nm;柱温:30℃。结果:18α-、18β-甘草酸分离度大于1.5,国内三个厂家的14批样品均为18α-、18β-两种构型的混合物,以18α-构型为主。HPLC法较UV法含量测定结果低10%以上。结论:甘草酸二铵产品为18α-、18β-两种构型的混合物,且产品中杂质较多,而国内现有药品标准均采用UV法,不能分离上述两种异构体,可采用本文方法测定含量并对其构型组成加以合理控制。
Objective： To establish an HPLC method for the determination of 18c^- and 1813- glycyrrhizic acid in diammonium glycyrrhizinate and its preparation. Methods： The HPLC method was performed on a Agilent HC-C18 （2） column （4.6 mm×250 mm, 5 μm）. The mobile phase was composed of acetonitrile-0.1 mol·L^-1 KH2PO4（adjust pH to 7.0 with 50% KOH）（22：78）. The flow rate was 1.0mL·min^-1 The detection wavelength was 250 nm. The column temperature was 30℃. Results： The resolution between 18α and 18β- glyeyrrhizic acid exceeded 1.5. Determination of diammonium glyeyrrhizinate products from domestic pharmaceutical factories of all 14 batches showed that diammonium glycyrrhizinate was all composed of 18α and 18β isomers, in which 18α was the main component. The contents by HPLC were 10% lower than those by UV method. Gonclusion： Glycyrrhizic acid in its products always consists of 18α anti 18β isomers, and many related substances existed. They can not be efficiently separated by available UV methods in domestic drug standards. The method above can be used for the determination of 18α- and 18β- glycyrrhizic acid for the quality control of glycyrrhizin products＇.
出处
《药学与临床研究》
2012年第1期34-37,共4页
Pharmaceutical and Clinical Research
