Objective: The HPLC method was established to determine the contents of glycine and cysteine-HCl in compound ammonium glycyrrhizinate injection, and ion chromatography was used to determine the contents of sulfite ion and its oxidation product sulfate ion, and the differences of amino acid stability and its causes of samples from different sources were studied and analyzed. Methods: Agilent Eclipse XDB-C18 column (150 mm×4.6 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. IonPac AS11-HC column (250 mm×4 mm) was used for ion chromatography, the eluent was 15 mmol·L-1 potassium hydroxide solution, and the detector was a conductivity detector. Results: The content of glycine in compound ammonium glycyrrhizinate injection from different manufacturers met the standard requirements. The contents of cysteine-HCl were 76.4%-94.3%, and that of sodium sulfite were 75.7%-96.1%. Conclusion: The new HPLC method needs no sample pretreatment and is accurate, which provids reference for the quality control of compound ammonium glycyrrhizinate Injection. Glycines in injection from different sources are stable. The contents of cysteine-HCl are uneven, and the contents in some samples are low and the stability is poor. The determination method of sodium sulfite by ion chromatography shows good stability and high accuracy. The contents of sodium sulfite in samples from different sources are different, and the oxidation of sodium sulfite and cysteine-HCl are synchronous during long-term storage, and the degradation degrees of samples from various enterprises are also different. Manufacturers need to further optimize the formulation and production process of preparations to control the degradation of unstable ingredients, thereby improving the quality of medicines.
XIE Sheng-gu, HUANG Yan, HE Jia-jia, SUN Xiao, NI Wei-fang, TAO Qiao-feng
. Study on the stability differences and degradation causes of amino acid in compound ammonium glycyrrhizinate injection from different sources*[J]. Chinese Journal of Pharmaceutical Analysis, 2023
, 43(2)
: 297
-304
.
DOI: 10.16155/j.0254-1793.2023.02.13
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