Determination of docusate sodium by ion-pair high-performance liquid chromatography
10.11665/j.issn.1000-5048.2024081002
- VernacularTitle:离子对高效液相色谱法测定多库酯钠的含量
- Author:
Lirong CAI
1
;
Haiping SHU
;
Sha XIAO
;
Yue TAN
;
Jinfeng ZHENG
;
Changliang LI
;
Yanming LIU
Author Information
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
- Publication Type:Journal Article
- Keywords:
docusate sodium;
ion-pair;
high performance liquid chromatography;
high-carbon-load chromato-graphic column
- From:
Journal of China Pharmaceutical University
2025;56(2):183-187
- CountryChina
- Language:Chinese
-
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.