HPLC法测定注射用三磷酸胞苷二钠的含量和有关物质  

Content Determination and Related Substances of Cytidine Disodium Triphosphate for Injection by HPLC

作　　者：张彤[1,2] 周长明[2] 纪宏[2] 韩南银[1] 

机构地区：[1]北京大学药学院,北京100091 [2]北京市药品检验所,北京100035

出　　处：《中国药房》2013年第5期453-455,共3页China Pharmacy

摘　　要：目的:建立测定注射用三磷酸胞苷二钠含量和有关物质的方法。方法:采用高效液相色谱法。以ThermoHypersilODSC18色谱柱为分析柱,以含反相离子对试剂的磷酸盐缓冲液为流动相,流速为1.0ml/min,柱温为30℃,检测波长为280nm;主药含量按峰面积以外标法计算,有关物质含量以主成分自身对照法计算。结果:三磷酸胞苷二钠检测质量浓度线性范围为90～1800mg/L(r=0.9997),平均回收率为102.1%(RSD=1.65%,n=9),定量限为7.4ng。结论:本方法操作简便、灵敏度高、重复性好、专属性和耐用性较强,可用于控制注射用三磷酸胞苷二钠的质量。OBJECTIVE： To establish the method for the content determination of Cytidine disodium triphosphate for injection and related substances. METHODS： HPLC method was adopted. The Thermo Hypersil ODS C18 column was used with mobile phase composed of reversed phase ion-pair reagent and phosphate buffer at the flow rate of 1.0 ml/min. The column temperature was set at 30 %, and the detection wavelength was set at 280 nm. The computation was performed with peak area by external stan- dard method, and the contents of related substance were calculated by self-control method. RESULTS： The linear range of cytidine disodium triphosphate was 90-1 800 mg/L （r=0.999 7） with an average recovery of 102.1% （RSD=1.65%, n=9）. The limit of quantity was 7.4 ng. CONCLUSIONS： The method is simple, sensitive and reproducible with sound specificity and reliability, and it can be used for quality control of cytidine disodium triphosphate for injection.

关 键 词：注射用三磷酸胞苷二钠 高效液相色谱法 有关物质 含量测定 

分 类 号：R927.2[医药卫生—药学]