注射用泮托拉唑钠中依地酸二钠含量分析方法的建立  

Establishment of method for disodium edetate in pantoprazole sodium for injection

作　　者：雷小平 杨明亮 姚吉勰 陈青连 LEI Xiaoping;YANG Mingliang;YAO Jixie;CHEN Qinglian(Hangzhou Ausia Biological Tech.Co.,Ltd.,Hangzhou 310018,China)

机构地区：[1]杭州澳亚生物技术股份有限公司,杭州310018

出　　处：《上海医药》2022年第5期77-80,共4页Shanghai Medical & Pharmaceutical Journal

摘　　要：目的:建立高效液相色谱法测定注射用泮托拉唑钠中依地酸二钠的含量。方法:采用十八烷基硅烷键合硅胶为填充剂的C_(18)色谱柱(4.6 mm×250 mm,5μm),以磷酸盐缓冲液-乙腈(90∶10)、乙腈进行梯度洗脱,流速为1.0 mL/min,检测波长为254 nm,柱温为35℃,进样体积为20μL。结果:依地酸二钠的检测不受其他成分干扰,不同浓度依地酸二钠的回收率均在98.0%~102.0%之间,回收率RSD为0.39%,浓度在27.52~64.20μg/mL范围内线性良好(r=1.0000)。结论:本方法简便、迅速、专属性及重现性好,可用于注射用泮托拉唑钠中依地酸二钠含量的测定。Objective: To establish a high performance liquid chromatography(HPLC) method for the determination of disodium edetate in pantoprazole sodium for injection. Methods: HPLC was performed using C_(18) column(4.6 mm×250 mm, 5 μm) with gradient elution containing phosphate buffer-acetonitrile(90:10)(A) and acetonitrile(B) at a flow rate of 1.0 m L/min, detection wavelength 254 nm, column temperature 35 ℃ and sample volume 20 μL. Results: The determination of disodium edetate was not interfered by other components in the injection. The recovery rates of different concentrations of disodium edetate were between 98.0%-102.0% with RSD 0.39%. Standard curve of disodium edetate showed good linearity over the range of 27.52-64.20 μg/m L with r=1.000 0. Conclusion: This method is simple, rapid, specific and reproduceable and can be used for the determination of disodium edetate in pantoprazole sodium for injection.

关 键 词：依地酸二钠 注射用泮托拉唑钠 含量 高效液相色谱法 

分 类 号：O657.72[理学—分析化学] R975.2[理学—化学]