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LI Xuan, HUANG Minwen, ZHOU Jie, YUAN Yaozuo, HANG Taijun. Chromatographic fingerprint and quality consistency of colistimethate sodium[J]. Journal of China Pharmaceutical University, 2023, 54(6): 749-756. DOI: 10.11665/j.issn.1000-5048.2023071903
Citation: LI Xuan, HUANG Minwen, ZHOU Jie, YUAN Yaozuo, HANG Taijun. Chromatographic fingerprint and quality consistency of colistimethate sodium[J]. Journal of China Pharmaceutical University, 2023, 54(6): 749-756. DOI: 10.11665/j.issn.1000-5048.2023071903

Chromatographic fingerprint and quality consistency of colistimethate sodium

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  • Received Date: July 18, 2023
  • Revised Date: December 10, 2023
  • The UPLC fingerprint of colistimethate sodium was established for the study of quality consistency.The chromatographic column was Acquity UPLC? Peptide CSH C18 (2.1 mm × 150 mm, 1.7 μm).The mobile phase A was phosphate buffer-acetonitrile (19∶1), and the mobile phase B was phosphate buffer-acetonitrile (1∶1).The mobile phase was in gradient elution at a flow rate of 0.3 mL/min.The column temperature was set at 30 °C and the detection wavelength was 210 nm.The similarity of the fingerprints was analyzed with the Similarity Evaluation System for Chromatographic Fingerprint of Tradition Chinese Medicine (Version 2012) in combination with content determination of multiple index components to evaluate the quality consistency of imported and domestic bulk drugs.The result showed that both the original and generic bulk drugs met the specified limit requirements in the European Pharmacopoeia standards, and that their UPLC fingerprints were highly similar, indicating that the quality of the two substances was consistent.Establishing a fingerprint for similarity evaluation and combining it with the results of indicator component content determination as a comprehensive evaluation method for the study of drug quality consistency of complex components has the characteristics of fast, accurate, and comprehensive, which is helpful for drug quality evaluation and provides ideas for the evaluation of antibiotic quality consistency of complex components.
  • [1]
    El-Sayed Ahmed MAE, Zhong LL, Shen C, et al. Colistin and its role in the Era of antibiotic resistance: an extended review (2000–2019) [J]. Emerg Microbes Infect, 2020, 9(1): 868-885.
    [2]
    He H, Li JC, Nation RL, et al. Pharmacokinetics of four different brands of colistimethate and formed colistin in rats[J]. J Antimicrob Chemother, 2013, 68(10): 2311-2317.
    [3]
    European Directorate for the Quality of Medicines & HealthCare. European Pharmacopeia 10.3:volume III(欧洲药典10.3:卷3)[S].France:European Directorate for the Quality of Medicine & Healthcare, 2020:4941-4944.
    [4]
    The United States Pharmacopeial Convention.The United States Pharmacopeial43-The National Formulary 38:volume III (美国药典43-国家处方集38:卷3)[S]. Rockville: The United States Pharmacopeial Convention, 2020:1148.
    [5]
    Pharmaceutical and Medical Device RegulatoryScience Society of Japan.Japanese Pharmacopeia XⅧ(日本药局方18版)[S]. Tokyo:Pharmaceutical and Medical Device Regulatory Science Society of Japan, 2021:810.
    [6]
    Qiao P, Jia M, Wang HL, et al. Quality evaluation of Ligusticum jeholense based on HPLC fingerprint and multi-component analysis[J]. Chin Tradit Herb Drugs (中草药), 2022, 53(5): 1512-1517.
    [7]
    Hu X, Wang HF, Yu FL, et al. Quality evaluation of Blumea balsamifera based on fingerprint analysis and quantitative analysis of multi-components[J]. Chin Tradit Herb Drugs (中草药), 2021, 52(12): 3679-3688.
    [8]
    Li ZY, Chen WH, Wang LW, et al. Study on UPLC fingerprint and chemical pattern recognition of Magnoliae Officinalis cortex from different origins[J]. Chin Tradit Herb Drugs (中草药), 2021, 52 (21):1-6.
    [9]
    Song Q, Liu H, Wang TM, et al. Quality evaluation of leaves of Juglans mandshurica based on combinative methods of HPLC fingerprint and multi-components determination and chemical pattern recognition[J]. Chin Tradit Herb Drugs (中草药), 2022, 53(7): 2143-2149.
    [10]
    Van den Bossche L, Van Schepdael A, Chopra S, et al. Identification of impurities in polymyxin B and colistin bulk sample using liquid chromatography coupled to mass spectrometry[J]. Talanta, 2011, 83(5): 1521-1529.
    [11]
    Sivanesan S, Roberts K, Wang JP, et al. Pharmacokinetics of the individual major components of polymyxin B and colistin in rats[J]. J Nat Prod, 2017, 80(1): 225-229.
    [12]
    Li J, Milne RW, Nation RL, et al. Pharmacokinetics of colistin methanesulphonate and colistin in rats following an intravenous dose of colistin methanesulphonate[J]. J Antimicrob Chemother, 2004, 53(5): 837-840.
    [13]
    Zhao M, Wu XJ, Fan YX, et al. Development and validation of a UHPLC-MS/MS assay for colistin methanesulphonate (CMS) and colistin in human plasma and urine using weak-cation exchange solid-phase extraction [J]. Journal of Pharmaceutical Biomedical Analysis, 2016, 124: 303-308.
    [14]
    European Medicines Agency. Assessment Report Polymyxin-Based Products[E]. London, UK, 2015.
    [15]
    Liu DF, Zhao LN, Li YF, et al. Research progress and application in fingerprint technology on Chinese materia medica[J]. Chin Tradit Herb Drugs (中草药), 2016, 47(22): 4085-4094.
    [16]
    Zhan H, Yan FR, Lu T. Research progress on data analysis methods in traditional Chinese medicine fingerprints[J]. J Anhui Agric Sci (安徽农业科学), 2017, 45(16): 203-205.
    [17]
    Guan HY, Li L, Liu X, et al. Study on similarity algorithm of traditional Chinese medicine fingerprints[J]. Chin J Exp Tradit Med Formulae (中国实验方剂学杂志), 2011, 17(18): 282-287.
    [18]
    Yang YT, Wu CY, Liu WL, et al. Study of the analysis result of the similarity of Danggui Buxue Decoction fingerprints by different methods[J]. China J Tradit Chin Med Pharm (中华中医药杂志), 2013, 28(5): 1431-1435.
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