HPLC法测定河豚毒素的含量及稳定性  

HPLC Determination of Tetrodoxin and Its Stability

作　　者：陈唯真[1] 朱维华[1] 俞如英[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《药物分析杂志》2004年第1期41-43,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立测定河豚毒素含量的反相高效液相色谱法,并用该方法对河豚毒素及注射剂的稳定性进行测定。方法:以ZORBAX C8(250 mm×4.6 mm,5μm)为色谱分析柱;0.02 mol·L-1磷酸氢二钠-0.02 mol·L-1磷酸二氢钾(1:1)为流动相;流速0.4 mL·min-1;UV检测波长210 nm,柱温为25℃。结果:河豚毒素在0.5～80μg·mL-1范围内线性关系良好,通过该方法的测定,河豚毒素及注射剂在光、热等因素的影响下,含量明显下降,杂质明显增加。结论:该方法可以为河豚毒素原料及注射剂的稳定性研究提供灵敏、准确的检测方法。河豚毒素及注射剂对光和热的稳定性较差,需避光,低温(0～4℃)保存。但河豚毒素原料对光的稳定性优于注射剂。Objective:To establish a HPLC method for determining of the stability of tetrodoxin and its injection. Method:A reverse -phase HPLC was used. The separation was performed on ZORBAX C8(250 mm ×4. 6 mm,5μm) column with the mobile phase of 0. 02 mol·L-1 Na2HPO4 -0. 02 mol· L-1 KH2PO4( 1: 1). The flow rate was 0. 4 mL · min-1. The detection was done at 210 nm and 25℃@ of column temperature. Results:The linear range for tetrodoxin was 0. 5 - 80 μg·mL-1. Under affecting factors such as light, heat and constant - temperature accelerated test,the content of tetrodoxin and its injection was increased by the HPLC. Conclusion:The method is a sensitive and accurate method for the determination of the stability. The stabilities of tetrodoxin and its injection were unstable to light and hest. Need to be stored at 0 - 4℃. The stability of tetrodoxin is obviously superior to that of its injection

关 键 词：HPLC法 测定 河豚毒素 含量 稳定性 

分 类 号：R282.74[医药卫生—中药学]