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Determination of Crosslinking Agent Residual in Cross-linked Sodium Hyaluronate Cell Scaffold

ZHANG Zhiyun;LIU Ronglei;CHEN Jianying;XING Yuren;WANG Qin;LING Peixue;Key Laboratory of Biopharmaceuticals,Shandong Academy of Pharmaceutical Science;Shandong Provincial Key Laboratory of Mucosal and Transdermal Drug Delivery Technologies,Shandong Freda Co. LTD;  
A method for determination of residual 1,4- butanediol diglycidyl ether( BDDE) in cross- linked sodium hyaluronate cell scaffold by GC chromatography was established. The method was programmed with Agilent HP- 5 capillary column( 30 m × 0. 32 mm,0. 25 μm) and FID detector. The carrier gas was nitrogen and the flow rate was 2. 0 ml·min- 1. The oven introduced sequential increasing of temperature programming. The initial column temperature was 90 ℃,then raised it to 250 ℃ at a rate of 15 ℃ ·min- 1,and maintained it for 8 min. The BDDE was quantified external standard. The calibration showed a good calibration linearity with the range of 0. 133 ~ 1. 865 μg·ml- 1for BDDE and the correlation coefficient was 0. 9993. The recoveries were in the range of 96. 33 %~ 100. 57 %. The relative standard deviations( RSD) was 1. 40 %( n = 9). The method has good specificity,repeatability and high sensitivity. It can be used for determining the content of residual BDDE in cross- linked sodium hyaluronate scaffold.
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