Chinese Journal of Pharmacovigilance ›› 2023, Vol. 20 ›› Issue (11): 1238-1242.
DOI: 10.19803/j.1672-8629.20230129

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Determination of contents of erythromycin cyclocarbonate tablets using HPLC method

HOU Jinfeng1, LI Min1, HUANG Xiaochun1, KOU Jinping1, CHE Baoquan1, LIU Haitao1,*, YAO Shangchen2#   

  1. 1Beijing Institute for Drug Control, NMPA Key Laboratory for Research and Evaluation of Generic Drugs, Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine, Beijing 102206, China;
    2National Institutes for Food and Drug Control, Beijing 100050,China
  • Received:2023-03-07 Online:2023-11-15 Published:2023-11-13

Abstract: Objective To establish an HPLC method for determination of the content of erythromycin cyclocarbonate (EMC) tablets. Methods EMC tablets were grinded and extracted with acetonitrile. The chromatographic separation was performed on a Waters Xbridge C18 column (250 mm×4.6 mm, 5μm) with an isocratic elution system composed of 0.02 mol·L-1 potassium hydrogen phosphate solution (adjust pH to 11.4 with 5 mol·L-1 potassium hydroxide solution)-acetonitrile (35 : 65) at a flow rate of 1.0 mL·min-1. The elutes were detected at the wavelength of 204 nm. Results A good linearity (r=0.9999) was observed within the range of 0.51 to 1.52 mg·mL-1. The recovery was between 99.0% and 100.5% (RSD=0.5%, n=9), the repeatability was 0.8% (n=6), and the intermediate precision was 0.9% (n=12). The test and standard sample solution remained stable for 10 hours at 5℃, and the method showed good durability. The contents of the three batches of EMC tablets were 102.3%, 102.0% and 103.5% respectively, which were within the current standard limit range of 93.0% to 107.0%. Conclusion This method is simple, rapid, accurate and specific, and is workable for the content determination of EMC tablets. A reference method has become available for the in-depth study of EMC and for the analysis of compounds with tautomeric structure by liquid chromatography.

Key words: erythromycin cyclocarbonate, tautomerism, assay, HPLC

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