Comparison of quantitative determination of principal component isomer and related substances of ammonium glycyrrhizinate by component and related substances of ammonium glycyrrhizinate by methods contained in different pharmacopoeias and a new method established by our laboratory / 中国药学杂志

ABSTRACT

OBJECTIVE: To determine and compare the contents of principal component and related substances of ammonium glycyrrhizinate by methods contained in different pharmacopoeias and a new method established by our lab. METHODS: The methods for quality control of ammonium glycyrrhizinate in the latest edition of European Pharmacopoeia, British Pharmacopoeia, national drug standards of China, and the method established by our laboratory were employed to determine the contents of the principal component isomers and related substances of ammonium glycyrrhizinate in its raw materials and pharmaceutical products. The methods were evaluated and compared regarding the chromatographic features, resolution of principal component isomers, experimental cost, content determination results, and the advantages and disadvantages of each method were discussed. RESULTS: The mobile phases adopted in aforementioned pharmacopoeias are all acidic, which could not effectively separate 18α-glycyrrhizinic acid and 18β-glycyrrhizinic acid, thus could not truly reflect the contents of 18α-glycyrrhizinic acid, 18β-glycyrrhizinic acid, related substances A, and the related substances in the raw materials and pharmaceutical products. The resolution of principal component isomer by our method was 1.5, complying to the pharmacopoeia requirement. The content determination results of ammonium glycyrrhizinate raw materials by the four methods had no significant difference. CONCLUSION: Among the four methods, the method established by our laboratory performed best in terms of accuracy and practicability. This method has shorter detection time, lower cost, reduced toxicity and pollution, and the results are accurate and reliable, which suggests that it can be used for the chiral resolution of 18α-glycyrrhizinic acid and 18β-glycyrrhizinic acid and the content determination of principal component and related substances of the raw material and pharmaceutical products of ammonium glycyrrhizinate. This study provideds reference for further revision of the quality control method in Pharmacopoeia.