替曲朵辛原料药含量和有关物质的测定及首批国家标准物质的标定  

Determination of the Content and Related Substance of Tetrodotoxin and First Batche of National Standard Material

作　　者：代秀梅[1,2] 于风平 张启明[2] 

机构地区：[1]淄博市食品药品检验所,山东淄博255086 [2]中国食品药品检定研究院,北京100050

出　　处：《中国药房》2013年第9期821-823,共3页China Pharmacy

摘　　要：目的:建立替曲朵辛原料药含量及有关物质的测定方法,并标定首批国家标准物质。方法:采用反相离子对高效液相色谱法。色谱柱为Agela Venusil AB S-C8(T),流动相为10mmol/L庚烷磺酸钠溶液(pH为3.0),流速为0.8ml/min,检测波长为195nm,柱温为35℃。结果:替曲朵辛检测质量浓度线性范围为0.294～44.16μg/m(lr=0.9999),检测限为48pg,首批国家标准物质的含量为每瓶15.12μg。结论:本方法操作简便、结果准确、重复性好,可用于作为替曲朵辛原料药含量测定和有关物质检查。OBJECTIVE：To establish a method for the determination of the content and related substance of tetrodotoxin,and to determine first batche of national standard material.METHODS：Ion-pair RP-HPLC method was adopted.The separation was performed on Agela Venusil ABS-C 8（T）column with mobile phase consisted of 10 mmol/L sodium heptanesulfonate（pH 3.0）at the flow rate of 0.8 ml/min.The detection wavelength was set at 195 nm and column temperature was 35 ℃.RESULTS：The linear range of tetrodotoxin was 0.294-44.16 μg/ml（r=0.999 9）with detection limit of 48 pg.The content of national standard material was 15.12 μg.CONCLUSIONS：The method is simple,accurate and reproducible.It can be applied for the determination of content and related substance of tetrodotoxin.

关 键 词：高效液相色谱法 替曲朵辛 含量测定 有关物质 标准物质 

分 类 号：R927.2[医药卫生—药学]