Quantitative determination method and application of pharmaceutical adjuvant tween 80.
10.19540/j.cnki.cjcmm.2018.0018
- Author:
Qian-Wen YANG
1
;
Ning WANG
1
;
Jie ZHANG
1
;
Hui XU
1
;
Zhi-Yong LI
2
Author Information
1. Center of Advanced Drug Delivery System and Biotech Drugs in Universities of Shandong, Key Laboratory of Molecular Pharmacology and Drug Evaluation, Ministry of Education, Yantai University, Yantai 264005, China.
2. State Key Laboratory of State Key Laboratory of Innovative Natural Medicine and Traditional Chinese Medicine Injections, Ganzhou 341000, China.
- Publication Type:Journal Article
- Keywords:
color reaction kinetics;
colorimetric method;
quantitative determination;
traditional Chinese medicine injection;
tween 80
- MeSH:
Adjuvants, Pharmaceutic;
chemistry;
Medicine, Chinese Traditional;
Polysorbates;
chemistry;
Quality Control;
Solvents;
Temperature
- From:
China Journal of Chinese Materia Medica
2018;43(4):743-747
- CountryChina
- Language:Chinese
-
Abstract:
Based on the fact that chromogenic reaction of blue complex, a reaction product which can be dissolved in organic solvents, can be realized by polyethoxy and ammonium thiocyanate in tween 80, a rapid and accurate way for the determination for tween 80 in pharmaceutical adjuvant was established in this study, providing reliable technical means for quality control of traditional Chinese medicine injections. Based on the study of reaction kinetics, chromogenic reaction temperature and time, as well as extraction of organic solvents and other key conditions were optimized, and Kumu injection was used as the test material for method validation and applicability investigation. It was finally determined that 3 mL ammonium thiocyanate solution was added in the sample solution, and the reaction was carried out in a boiling water bath for 2 h. After cooling to room temperature, 5 mL of dichloromethane was added to extract the chromogenic product. The absorbance value was measured at the wavelength of 623 nm to calculate the tween 80 content in the sample. Under optimized conditions, tween 80 solution showed a good linear relationship with the absorbance in the range from 0.8 mg to 3.0 mg. The linear regression equation was ＝0.258-0.047. The correlation coefficient was 0.999 6. Under the experimental conditions, the average recovery was 99.66%, and the precision RSD was less than 2.0%. The results showed that this method can quickly and accurately determine the content of tween 80 in Kumu injection, and it could be applicable to the quality control of traditional Chinese medicine injections.
