Quality Control

Quantitative determination and stability evaluation of amino acids in compound glycyrrhizin injection from different sources*

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  • 1. Zhejiang University of Technology,Hangzhou 310014;
    2. Zhejiang Institute for Food and Drug Control,National Medical Products Administration Key Laboratory for Core Technology of Generic Drug Evaluation,Hangzhou 310052,China

Received date: 2021-01-14

  Online published: 2024-07-15

Abstract

Objective: To establish an HPLC method for the determination of glycine and cysteine hydrochloride in compound glycyrrhizin injection from different sources,and to investigate and evaluate the stability of degradable amino acids. Methods: Agilent Eclipse XDB-C18 column (4.6 mm×150 mm,5 μm) was used. The mobile phase was methanol-0.01 mol·L-1 phosphate buffer (adjusted to pH 2.15±0.02 with phosphoric acid) (5∶95). The detection wavelength was 210 nm. Results: The content of glycine in compound glycyrrhizin injection from different manufacturers was 99.1%-101.7%;the average content of cysteine hydrochloride from brand manufacturer was 103.9%,and cystine was not detected. In samples from generic manufacturers,the content of cysteine hydrochloride was 50.7%-85.6%,and cystine was detected. Conclusion: This method needs no sample pretreatment and has high accuracy,which can provide reference for the quality control of compound glycyrrhizin injection. Glycine in injections from different manufacturers is relatively stable;the content of cysteine hydrochloride varies considerably and some samples have low content and poor stability. The stability of cysteine hydrochloride is closely related to pH value and formulation. The stability of injections from different sources varies greatly. Some generic drug manufacturers need to further optimize the formulation process and improve the quality of drugs.

Cite this article

HUANG Yan, SUN Xiao, HE Jia-jia, SUN Nan, XIE Sheng-gu . Quantitative determination and stability evaluation of amino acids in compound glycyrrhizin injection from different sources*[J]. Chinese Journal of Pharmaceutical Analysis, 2021 , 41(9) : 1655 -1662 . DOI: 10.16155/j.0254-1793.2021.09.20

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