Improvement on the determination method of sodium alginate pharmaceutical excipient
10.19778/j.chp.2024.04.014
- VernacularTitle:药用辅料海藻酸钠含量测定方法改进
- Author:
Xuan KONG
1
;
Yan WU
;
Panpan HU
Author Information
1. 天津市药品检验研究院,天津 300070
- Keywords:
pharmaceutical excipient;
sodium alginate;
acid-water precipitation;
acid-isopropanol precipitation;
volumetric analysis;
content assay
- From:
Drug Standards of China
2024;25(4):405-408
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To improve the determination method of sodium alginate pharmaceutical excipient in the USP for the analysis of sodium alginate content in the Chinese market.Methods:High and low viscosity sodium alginate samples were subject to acid-water and acid-isopropanol precipitation methods,respectively,followed by acid-base neutralization capacity analysis to calculate the sodium alginate content in the sample.Results:The line-ar relations were good between sample weight and the volume of sodium hydroxide titrant consumed in the range of 0.5-1.5g(R2=1.000 0,0.999 9).For two precipitation methods,the average recovery rates were 104.2％with RSD value of 0.3％(n=6)and 101.9％with RSD value of 0.2％(n=6),respectively.Conclusion:The improved method has good specificity,accuracy and precision,which is convenient and low cost that can be performed in the assay of sodium alginate pharmaceutical excipient.
