Determination of residual cross-linker vinyl sulfone in sodium hyaluronate injection
- VernacularTitle:交联玻璃酸钠注射液中残留交联剂乙烯砜的测定
- Author:
Yue WANG
;
Jing LI
;
Huihong FAN
- Publication Type:Journal Article
- Keywords:
cross-linked sodium hyaluronate injection;
vinyl sulfone;
hydration product of vinyl sulfone;
1,4-Thioxane-1,1-Dioxide;
Gas Chromatography
- From:
Chinese Journal of Biochemical Pharmaceutics
2014;37(4):171-174
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish a method to quantify the residual cross-linker vinyl sulfone and its hydration product 1 ,4-Thioxane-1 ,1-Dioxide.Methods The polysaccharide was precipitated by ethanol,however vinyl sulfone and its hydration product were soluble,and can be analyzed by direct injection.The analysis was carried on Agilent DB-wax capillary column (30m ×0.53 mm,1.0 μm).The flame ionization detector (FID)and flame photometric detector (FPD)were used to detect samples and the efficiency were compared. Results The linear range of vinyl sulfone and its hydration product were separately 0.5 ~20μg/mL and 2~100μg/mL detected by FID.The Limit of Quantity (LOQ)were 0.8μg/mL and 2.3μg/mL, respctively.The Limit of Detection (LOD)were 2.6μg/mLand 7.6μg/mL,respectively,and the average recoveries (n=9)of them were 104.3%and 92.4%,respectively.Conclusion FID could meet the needs of the test,and this method is simple and accurate with high sensitivity and good repeatability,which can be used for quality control of trace vinyl sulfone and its hydration products 1 ,4-Thioxane-1 ,1-Dioxide in cross-linked sodium hyaluronate injection.
