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CAI Lirong, SHU Haiping, XIAO Sha, et al. Determination of docusate sodium by ion-pair high-performance liquid chromatography[J]. J China Pharm Univ, 2025, 56(2): 183 − 187. DOI: 10.11665/j.issn.1000-5048.2024081002
Citation: CAI Lirong, SHU Haiping, XIAO Sha, et al. Determination of docusate sodium by ion-pair high-performance liquid chromatography[J]. J China Pharm Univ, 2025, 56(2): 183 − 187. DOI: 10.11665/j.issn.1000-5048.2024081002

Determination of docusate sodium by ion-pair high-performance liquid chromatography

Funds: This study was supported by the Hunan Provincial Natural Science Foundation of China(2023JJ60106)and the NMPA Key Laboratory for Research and Evaluation of Pharmaceutical Preparation and Excipients Foundation(PPE2023008)
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  • Received Date: August 09, 2024
  • To reduce the dependency on high-carbon-load chromatographic columns,a new method has been established for the determination of the content of docusate sodium using ion-pair high-performance liquid chromatography (IP-HPLC). Tetrapropylammonium chloride was used as the ion-pair reagent with a mobile phase, composition of acetonitrile:10 mmol/L tetrapropylammonium chloride solution = 66∶34, adjusting pH to 6.5 with 0.1% phosphoric acid solution,flow rate of 1.5 mL/min, detection wavelength of 214 nm,column temperature of 35 °C, and an injection volume of 25 μL,and quantified by an external standard method. The main peak of docusate sodium exhibited a tailing factor of 1.34. The method showed good linearity within the range of 0.02 mg/mL to 0.40 mg/mL, with a correlation coefficient (r) of 0.999 9. It also demonstrated good repeatability, with recovery ranging from 97.0% to 98.2% (n=6). The quantification limit was 3.31 μg/mL, and the detection limit was 2.76 μg/mL.In summary,the new method shows good durability, a wide linear range, and high sensitivity, it is suitable for the determination of docusate sodium.

  • [1]
    The European Pharmacopoeia Commission. The European Pharmacopoeia: 11.0thEd[S]. Strasbourg: Council of Europe, 2022: 2584-2585.
    [2]
    The United States Pharmacopeial Convention. USP-NF[S/OL]. Docusate sodium, 2018, [2023-08-01]. https://doi.org/10.31003/USPNF_M27920_03_01.
    [3]
    Chinese Pharmacopoeia Commission, China Pharmacopoeia 2020 edition first supplement(中华人民共和国药典2020版第一增补本)[S]. Beijing: China Medical Science Press, 2023: 688-689.
    [4]
    State Administration for Market Regulation, National Standardization Administration. GB/T 5173—2018, Surface active agents-detergents-determination of anionic-active matter content-Direct two-phase titration procedure(表面活性剂洗涤剂阴离子活性物含量的测定直接两相滴定法)[S]. Beijing: China Standard Press, 2018.
    [5]
    The United States Pharmacopeial Convention. The United States Pharmacopeial 20-The National Formulary 15(美国药典20-国家处方集15)[S]. U. S. Pharmacopeial Convention: Rockville: The United States Pharmacopeial Convention, 1980: 262.
    [6]
    The United States Pharmacopeial Convention,USP-NF[S/OL]. Docusate Sodium Capsules, 2013 [2023-08-01]. https://doi.org/10.31003/USPNF_M27930_01_01.1.
    [7]
    Zeng DR, He JG, Study on the determination of sorbitol and docusate sodium related impurity[D]. Guangzhou: Sun Yat-sen University, 2009.
    [8]
    Gao Q, Zhao M. Determination of mesalazine and gentisic acid in pentasa rectal suspension by RP-HPLC[J]. J China pharm Univ(中国药科大学学报), 1999, 30(5): 370-372.
    [9]
    Shi PJ, Wu J, Xin ZQ, et al. Influence of sodium alkyl sulfonate ion-pair reagents on retention behavior of alkaloids in Arecae Semen[J]. Chin J Pharm Anal(药物分析杂志), 2023, 43(6): 975-981.
    [10]
    Chen LG, Zhou JH, Sun WZ, et al. The changing rules of the retention characteristics of an ion exchange column and countermeasures[J]. J Instrument Anal(分析测试学报), 2008, 27(2): 203-205.
    [11]
    Liu XL, GaoW, Liang C, et al. Effects of buffer salt types and non-counter ions of ion-pair reagents on the retention behavior of strongly ionized acid compounds in ion-pair reversed-phase liquid chromatography[J]. Chin J Chromatogr(色谱), 2021, 39(9): 1021-1029.
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