高效液相色谱法测定天然胶乳橡胶避孕套中苯佐卡因的含量  

Determination of Benzocaine in Natural Latex Rubber Condom by High Performance Liquid Chromatography

作　　者：魏嫣 梅享林 李玲 余诗琪 叶上诗 田荻 WEI Yan;MEI Xiang-lin;LI Ling;YU Shi-qi;YE Shang-shi;TIAN Di(Hubei Medical Devices Quality Supervision and Test Institute,Hubei Wuhan 430075)

机构地区：[1]湖北省医疗器械质量监督检验研究院,湖北武汉430075

出　　处：《中国医疗器械信息》2023年第17期35-37,70,共4页China Medical Device Information

摘　　要：目的:建立高效液相色谱法测定天然胶乳橡胶避孕套中苯佐卡因含量的方法。方法:天然胶乳橡胶避孕套加入100mL流动相经过超声萃取后,以XBridgeC185μm(4.6mm×250mm,5μm)色谱柱进行分离;采用流动相:甲醇:水:冰醋酸(80:20:0.5);检测波长为283nm;流速:0.5mL/min;柱温:35℃。结果:苯佐卡因含量测定在进样浓度0.957~95.744μg/mL的范围内呈良好的线性关系,相关系数r=0.9999,低浓度回收率为99.58%,RSD=2.8%;高浓度回收率为101.2%,RSD=1.0%;在低浓度和高浓度的两个添加水平范围内准确率和重复性良好。结论:该方法快速简便,重复性好,结果准确可靠,可用于天然胶乳橡胶避孕套中苯佐卡因含量测定。Objective:To establisha HPLC method forthedeterminingof benzocaine in natural latex rubber candoms.Methods:The natural latex rubber condom was added to 100mL of mobile phase and extracted under ultrasonication.The chromatographic column was XBridge C185μm(4.6mm×250mm,5μm).Mobile phase:methanol:water:glacial acetic acid(80:20:0.5);Detection wavelength:283nm;Flow rate:0.5mL/min;Column temperature:35℃.Results:Benzocaine content showed a good linear relationship between the injection concentration of 0.957-95.744μg/mL,r=0.9999,the low concentration recovery was 99.58%,RSD=2.8%;The high concentration recovery was 101.2%,RSD=1.0%.Good accuracy and repeatability in the range of two addition levels of low and high concentrations.Conclusion:The method is rapid,simple,reproducible,accurate and reliable,and can be used for the determination of benzocaine in natural latex rubber condoms.

关 键 词：高效液相色谱法:苯佐卡因 天然胶乳橡胶避孕套 含量测定 

分 类 号：R113[医药卫生—公共卫生与预防医学]