HPLC法测定泊沙康唑注射液中乙二胺四乙酸二钠的含量  

Determination of Disodium Edetate in Posaconazole Injection by HPLC

作　　者：胡裕迪 朱硕然 印玺璟 施方震 赵雁[1] HU Yudi;ZHU Shuoran;YIN Xijing;SHI Fangzhen;ZHAO Yan(National Pharmaceutical Engineering and Research Center, China State Institute of Pharmaceutical Industry, Shanghai 201203)

机构地区：[1]中国医药工业研究总院药物制剂国家工程研究中心

出　　处：《中国医药工业杂志》2019年第7期786-791,共6页Chinese Journal of Pharmaceuticals

基　　金：十三五专项“新型注射剂辅料磺丁基倍他环糊精钠技术开发及应用(泊沙康唑注射液)”(2018ZX09721002-006);上海市科委研发平台专项(18DZ2290500)

摘　　要：建立了高效液相色谱法测定泊沙康唑注射液中的螯合剂乙二胺四乙酸二钠(EDTA-2Na)。供试品溶液加铜离子(Cu2+)络合EDTA-2Na、加碱超声沉淀泊沙康唑。采用Eclipse XDB C18色谱柱,流动相为乙腈∶20 mmol/L四丁基硫酸氢铵(TBAHS,用氢氧化钠调至pH 3.0)∶水,梯度洗脱,柱温30℃,紫外检测波长254 nm,流速0.8 ml/min,进样量5μl。EDTA-2Na在0.5~30μg/ml浓度范围内线性关系良好(r^2=0.999 5)。平均回收率为100.0%,RSD为0.91%。An HPLC method was established for the determination of disodium edetate(EDTA-2Na)in posaconazole injection. Sample solution was treated by chelation with Cu2+, precipitation with sodium hydroxide solution under ultrosonic. An Eclipse XDB C18 column was used, with the mobile phase of acetonitrile∶20 mmol/L tetrabutylammonium hydrogen sulfate(TBAHS, adjusted to pH 3.0 with sodium hydroxide)∶water using gradient elution. The column temperature was 30 ℃, the detection wavelength was 254 nm and the flow rate was 0.8 ml/min, the amount of injection was 5 μl. It was linear for EDTA-2Na in the range of 0.5-30 μg/ml. The average recovery was 100.0%, with RSD of 0.91%.

关 键 词：泊沙康唑注射液 乙二胺四乙酸二钠 高效液相色谱法 含量测定 

分 类 号：O652.63[理学—分析化学]