|本期目录/Table of Contents|

[1]赵亚绘,王彦竹,宋丽明,等.丁酸氯维地平注射乳剂中依地酸二钠的含量测定[J].天津医科大学学报,2016,22(01):73-75.
　ZHAO Ya-hui,WANG Yan-zhu,SONG Li-ming,et al.Determination of EDTA-2Na in clevidipine butyrate injectable emulsion[J].Journal of Tianjin Medical University,2016,22(01):73-75.
点击复制

丁酸氯维地平注射乳剂中依地酸二钠的含量测定(PDF)
分享到：

《天津医科大学学报》[ISSN:1006-8147/CN:12-1259/R]

卷:
22卷
期数:
2016年01期
页码:
73-75
栏目:
技术与方法
出版日期:
2016-01-20

文章信息/Info

Title:
Determination of EDTA-2Na in clevidipine butyrate injectable emulsion
文章编号:
1006-8147（2016）01-0073-03
作者:
赵亚绘1; 2; 王彦竹2; 宋丽明2; 张赫然2; 王杏林2*; 田 沛1; 2
（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）
Author(s):
ZHAO Ya-hui1; 2;  WANG Yan-zhu2;  SONG Li-ming2;  ZHANG He-ran2;  WANG Xing-lin2*;  TIAN Pei1; 2
(1．Graduate School ，Tianjin Medical University, Tianjin 300070, China; 2 Tianjin Institute of Pharmaceutical Research Co., Ltd. State Key Laboratory of Drug Delivery Technology and Pharmacokinetics, Tianjin 300193, China)
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
Keywords:
clevidipine butyrate;  injectable emulsion;  EDTA-2Na;  HPLC; content
分类号:
R927.2
DOI:
-
文献标志码:
A
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，5 μm)，梯度洗脱流动相A为0.66 %四丁基氢氧化铵溶液-乙腈(3:1)(pH6.5)，B相为甲醇-水(9:1)，流速为1.0 mL·min-1，进样量50 μL，检测波长为254 nm。结果：依地酸二钠峰不受辅料干扰，在8.04~80.37 ?g·mL-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0.402 μg，供试品中依地酸二钠含量分别为46.7 μg·mL-1、47.0 μg·mL-1、49.6 μg·mL-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。
Abstract:
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 mm, 5 μm) 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 50 μL and the detection wavelength was 254 nm. Results: EDAT-2Na in clevidipine butyrate injectable emulsion could be detected without excipients interfering. Calibration curve was linear range of 8.04-80.37 ?g·mL-1 (r=0.9999), the average recovery rate was 97.78%(n=9, RSD=0.62%), and the limit of quantitation was 0.402 μg and the determination of EDTA-2Na in the three batches of tests were 46.7 μg·mL-1，47.0 μg·mL-1，49.6 μg·mL-1respectively. Conclusion: This method is accurate, reliable, exclusive, so it can be used for the determination of EDTA-2Na in clevidipine butyrate injectable emulsion.

参考文献/References:

[1]Keating G M. Clevidipine: a review of its use for managing blood pressure in perioperative and intensive care settings[J]. Drugs, 2014, 74(16): 1947.

[2]Wei H H, Gu Y, Liu Y P, et al. Quantitation of clevidipine in dog blood by liquid chromatography tandem mass spectrometry: application to a pharmacokinetic study[J]. J Chromatogr B Analyt Technol Biomed Life Sci, 2014, 971: 52

[3]Kurnutala L N, Soghomonyan S, Bergese S D. Perioperative acute hypertension-role of Clevidipine butyrate[J]. Front Pharmacol, 2014, 5: 197

[4]Mirtallo J M, Dasta J F, Kleinschmidt K C, et al. State of the art review: Intravenous fat emulsions: Current applications, safety profile, and clinical implications[J]. Ann Pharmacother, 2010, 44(4): 688.

[5]He J Q, Zhang H Y, Yang L, et al. Preparation and evaluation of intravenous tetrandrine emulsion[J]. Chin Pharm J, 2011, 46(22): 1734

[6]Xiao S G. The latest National standard pharmaceutical excipients[M]. Beijing: The medicine science and technology press of China, 2010: 50

[7] 中国药典2010版. 二部 [S]. 2010: 1206

[8]欧洲药典.6.0版 [S]. 2008:234

相似文献/References:

备注/Memo

备注/Memo:
基金项目 国家重大新药创制课题基金资助 (2014ZX09507005-001)

作者简介 赵亚绘(1990-)，女，硕士在读，研究方向：药物制剂； 通信作者:王杏林， E-mail: wangxl@tjipr.com。

更新日期/Last Update: 2016-01-26