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离子对高效液相色谱法测定多库酯钠的含量

蔡立荣 舒海平 肖莎 谭跃 郑金凤 李昌亮 刘雁鸣

中国药科大学学报2025,Vol.56Issue(2):183-187,5.
中国药科大学学报2025,Vol.56Issue(2):183-187,5.DOI:10.11665/j.issn.1000-5048.2024081002

离子对高效液相色谱法测定多库酯钠的含量

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

蔡立荣 1舒海平 2肖莎 2谭跃 2郑金凤 3李昌亮 3刘雁鸣3

作者信息

  • 1. 湖南省药品检验检测研究院,国家药监局药用辅料工程技术研究重点实验室,长沙 410001||国家药监局药物制剂及辅料研究与评价重点实验室,南京 211198
  • 2. 湖南华纳大药厂股份有限公司,长沙 410006
  • 3. 湖南省药品检验检测研究院,国家药监局药用辅料工程技术研究重点实验室,长沙 410001
  • 折叠

摘要

Abstract

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℃,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.

关键词

多库酯钠/离子对/高效液相色谱法/高载碳量色谱柱

Key words

docusate sodium/ion-pair/high performance liquid chromatography/high-carbon-load chromato-graphic column

分类

药学

引用本文复制引用

蔡立荣,舒海平,肖莎,谭跃,郑金凤,李昌亮,刘雁鸣..离子对高效液相色谱法测定多库酯钠的含量[J].中国药科大学学报,2025,56(2):183-187,5.

基金项目

湖南省自然科学基金科药联合基金项目(2023JJ60106) (2023JJ60106)

国家药监局药物制剂及辅料研究与评价重点实验室开放课题(PPE2023008) 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) (PPE2023008)

中国药科大学学报

OA北大核心

1000-5048

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