丁酸氯维地平注射乳剂中依地酸二钠的含量测定  

Determination of EDTA-2Na in clevidipine butyrate injectable emulsion

作　　者：赵亚绘 王彦竹[2] 宋丽明[2] 张赫然[2] 王杏林[2] 田沛[1,2] 

机构地区：[1]天津医科大学研究生院,天津300070 [2]天津药物研究院有限公司,释药技术与药代动力学国家重点实验室,天津300193

出　　处：《天津医科大学学报》2016年第1期73-75,79,共4页Journal of Tianjin Medical University

基　　金：国家重大新药创制课题基金资助(2014ZX09507005-001)

摘　　要：目的:建立测定丁酸氯维地平注射乳剂中微量依地酸二钠的高效液相色谱法。方法:采用Agilent ZORBAX Extend-C18柱(150 mm×4.6 mm,5μm),梯度洗脱流动相A为0.66%四丁基氢氧化铵溶液-乙腈(3∶1)(p H6.5),B相为甲醇-水(9∶1),流速为1.0 m L·min-1,进样量50μL,检测波长为254 nm。结果:依地酸二钠峰不受辅料干扰,在8.04~80.37μg·m L^(-1)内线性关系良好(r=0.999 9),加样回收率为97.78%(n=9,RSD=0.62%),定量限0.402μg,供试品中依地酸二钠含量分别为46.7μg·m L^(-1)、47.0μg·m L^(-1)、49.6μg·m L^(-1)。结论:该方法准确可靠、专属性强,可用于丁酸氯维地平注射乳剂中依地酸二钠的含量测定。Objective： To establish an HPLC method for determination of tracing EDTA -2Na in clevidipine butyrate injectable emulsion. Methods： The determination was performed on Agilent ZORBAX Extend-C18 column （150 mm×4.6 ram, 5μm） with gradient elution, mobile phase A was 0.66% tetrabutylammonium hydroxide solution-acetonitrile （3：1） （pH was adjusted to 6.5 ）,and mobile phase B was methanol-water （9：1）, the flow rate was 1.0 mL·min^-1 and the injection volume was 50μL and the detection wavelength was 254 nm. Results： EDTA-2Na in clevidipine butyrate injectable emulsion could be detected without excipients interfering. Calibration curve was linear range of 8.04-80.37μg·mL-1 （r=0.999 9）, the average recovery rate was 97.78%（n=9, RSD=0.62%）, and the limit of quantitation was 0.402μg and the determination of EDTA-2Na in the three batches of tests were 46.7 μg·mL^-1, 47.0μg·mL^-1,49.6μg·mL^-1 respectively. Conclusion： This method is accurate, reliable, exclusive, so it can be used for the determination of EDTA-2Na in clevidipine butyrate injectable emulsion.

关 键 词：丁酸氯维地平 注射乳剂 依地酸二钠 高效液相色谱法 含量 

分 类 号：R927.2[医药卫生—药学]