Standard Deliberation

Evaluation and application of HPLC-ELSD in impurity profile detection of kanamycin sulfate injection*

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  • Shanghai Institute for Food and Drug Control,Shanghai 201203,China

Received date: 2020-03-01

  Online published: 2024-05-31

Abstract

Objective: To optimize and establish an HPLC-ELSD method,and determine the related substances in kanamycin sulfate injection from different sources in order to evaluate its suitability in the analysis of aminoglycoside antibiotics by a series of methodological studies,especially the specificity. Methods: A Welch LP-C18 column(4.6 mm×250 mm,5 μm) was used,and the mobile phase was 0.2 mol·L-1 trifluoroacetic acid solution-methanol(98:2) at a flow rate of 0.3 mL·min-1.ELSD detector was used on splitless mode. Results: Satisfied resolutions were obtained among different related process impurities,different degraded impurities,as well as kanamycin and different excipients. And mass balance was proved through the specificity tests.The method could be used for comprehensive analysis of the impurity profile of kanamycin sulfate injection. Conclusion: The optimized method will play an important role in fast quality evaluation of kanamycin and its injection.The ELSD method is proved with better specificity,more efficiency,lower costs and easier to be popularized than other methods.

Cite this article

ZHAO Jing-dan, LIU Hao . Evaluation and application of HPLC-ELSD in impurity profile detection of kanamycin sulfate injection*[J]. Chinese Journal of Pharmaceutical Analysis, 2021 , 41(1) : 117 -123 . DOI: 10.16155/j.0254-1793.2021.01.14

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