Development and validation of a sensitive HPLC method for the determination of lisinopril in human plasma after derivatization with 4-fluoro-7-nitro-2,1,3-benzoxadiazole

doi:10.5246/jcps.2018.09.064

中国药学(英文版) ›› 2018, Vol. 27 ›› Issue (9): 623-629.DOI: 10.5246/jcps.2018.09.064

Development and validation of a sensitive HPLC method for the determination of lisinopril in human plasma after derivatization with 4-fluoro-7-nitro-2,1,3-benzoxadiazole

Reza Ahmadkhaniha¹, Noushin Rastkari², Syed Husain Hashemi Mousavi³, Effat Souri^4*

1. Department of Human Ecology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
2. Center for Air Pollution Research (CAPR), Institute for Environmental Research (IER), Tehran University of Medical Sciences, Tehran, Iran
3. Department of Chemistry, Faculty of Engineering, South Tehran Branch, Islamic Azad University, Tehran, Iran
4. Department of Medicinal Chemistry, Faculty of Pharmacy and Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, Tehran, Iran

收稿日期:2018-04-13 修回日期:2018-06-20 出版日期:2018-09-29 发布日期:2018-07-11
通讯作者: Tel.: +98-21-66959065; Fax: +98-21-66461178, E-mail: souri@sina.tums.ac.ir
基金资助:
The part of a Pham D thesis supported by Tehran University of Medical Sciences (Grant No. 23049-92-02-92).

Development and validation of a sensitive HPLC method for the determination of lisinopril in human plasma after derivatization with 4-fluoro-7-nitro-2,1,3-benzoxadiazole

Reza Ahmadkhaniha¹, Noushin Rastkari², Syed Husain Hashemi Mousavi³, Effat Souri^4*

1. Department of Human Ecology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
2. Center for Air Pollution Research (CAPR), Institute for Environmental Research (IER), Tehran University of Medical Sciences, Tehran, Iran
3. Department of Chemistry, Faculty of Engineering, South Tehran Branch, Islamic Azad University, Tehran, Iran
4. Department of Medicinal Chemistry, Faculty of Pharmacy and Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, Tehran, Iran

Received:2018-04-13 Revised:2018-06-20 Online:2018-09-29 Published:2018-07-11
Contact: Tel.: +98-21-66959065; Fax: +98-21-66461178, E-mail: souri@sina.tums.ac.ir
Supported by:
The part of a Pham D thesis supported by Tehran University of Medical Sciences (Grant No. 23049-92-02-92).

摘要/Abstract

摘要：

In this study, we developed a simple and sensitive HPLC method for the determination of lisinopril in human plasma. The sample clean-up was carried out by solid-phase extraction (SPE) using a cation-exchange (Strata-SCX^®) extraction cartridge. After a pre-column derivatization with 4-fluoro-7-nitro-2,1,3-benzoxadiazole, the reaction mixture was analyzed on an Agilent Zorbax SB^®-C₁₈ (150 mm×4.6 mm, 5 μm). The flow rate was set at 1.0 mL/min. Fluorescence detection was performed at an excitation wavelength of 470 nm and an emission wavelength of 530 nm. The mobile phase consisted of a mixture of methanol and 0.02 M sodium dihydrogen phosphate (pH = 3.0, 60:40, v/v). The average extraction recovery of lisinopril and fluvoxamine (internal standard) was >85%. The method exhibited a linear calibration curve over the concentration range of 1–1000 ng/mL with a correlation coefficient (r²) of ≥0.98 and a limit of quantification (LOQ) equal to 2 ng/mL. The within-run and between-run precisions were satisfactory with an RSD of 3.8%–13.7% (accuracy: from 95.0% to 96.4%) and 4.273%–14.3% (accuracy: from 94.4% to 98.5%), respectively.

关键词: Lisinopril, HPLC, Derivatization, 4-Fluoro-7-nitro-2,1,3,-benzoxadiazole

Abstract:

Key words: Lisinopril, HPLC, Derivatization, 4-Fluoro-7-nitro-2,1,3,-benzoxadiazole

中图分类号:

R917

Supporting:

Reza Ahmadkhaniha, Noushin Rastkari, Syed Husain Hashemi Mousavi, Effat Souri. Development and validation of a sensitive HPLC method for the determination of lisinopril in human plasma after derivatization with 4-fluoro-7-nitro-2,1,3-benzoxadiazole[J]. 中国药学(英文版), 2018, 27(9): 623-629.

参考文献

[1] Brayfield A. (Ed.), Martindale: The Complete Drug Reference, 38th Edition, Pharmaceutical Press, London 2014.

[2] Sukalo, A.; Deljo, D.; Krupalija, A.; Zjajo, N.; Kos, S.; Curic, A.; Divkovic, G.; Hubjar, S.; Smailagic, M.; Hodzic, E.; Marjanovic, D.; Medjedovic, S. Med. Arch. 2016, 70, 299-302.

[3] Xasan, M.; Muzaffar, U.; Akhmedov, I.; Hojiev, S.; Uzoqova, M.; Yakhshiboev, D.; Dadaev, S. J. Hypertension. 2016, 34, 14-58.

[4] Wong Y.; Charles B.G. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 1989, 75, 512-516.

[5] El-Emam, A.A.; Hansen, S.H.; Moustafa, M.A.; El-Ashry, S.M.; El-Sherbiny, D.T. J. Pharm. Biomed. Anal. 2004, 34, 35-44.

[6] Shah, J.; Shah, P.A.; Shah, P.V.; Samyal, M.; Shrivastav, P.S. J. Pharm. Anal. 2016, DOI: 10.1016/j.jpha.2016.11.004.

[7] Qin, F.; Wang, D.; Yang, S.; Jing, L.; Xiong, Z.; Li, F. Biomed. Chromatogr. 2012, 26, 691-696.

[8] Leis, H.J.; Fauler, G.; Raspotnig, G. Windischhofer, W. Rapid Commun. Mass Spectrom. 1998, 12, 1591-1594.

[9] Leis, H.J.; Faulter, G.; Windischhofer, W. Rapid Commun. Mass Spectrom. 1999, 13, 650-653.

[10] Rastkari, N.; Khoobi, M.; Shafiee, A.; Khoshayand, M.R.; Ahmadkhaniha, R. J. Chromatogr. B Anal. Technol. Biomed. Life Sci. 2013, 932, 144-151.

[11] Analytical Procedures and Methods Validation for Drugs and Biologics, Guidance for Industry, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), 2015.

[12] Bulletin of the World Health Organization, 2001, 79, 373-374.

[13] Zhang, K.; Liu, X. J. Pharm. Biomed. Anal. 2016, 128, 73-88.

[14] Higashi, Y.; Matsumura, H.; Fujii, Y. Biomed. Chromatogr. 2005, 19, 771-776.

[15] Tamimi, J.J.I.; Salem, I.I.; Alam, S.M.; Zaman, Q.; Ruwayda, D. Biopharm. Drug Dispos. 2005, 26, 335-339.

Development and validation of a sensitive HPLC method for the determination of lisinopril in human plasma after derivatization with 4-fluoro-7-nitro-2,1,3-benzoxadiazole

Development and validation of a sensitive HPLC method for the determination of lisinopril in human plasma after derivatization with 4-fluoro-7-nitro-2,1,3-benzoxadiazole

RichHTML

PDF (PC)

可视化

摘要/Abstract

引用本文

使用本文

参考文献

相关文章 15

编辑推荐

Metrics

本文评价

[1]	周燕青, 刘永红, 李艳婷, 陶彦如, 李进, 蒋心惠. HPLC-PDA 测定黄桷树叶提取液中绿原酸和芦丁的含量[J]. 中国药学(英文版), 2023, 32(1): 45-51.
[2]	金祥飞, 程闽玥, 钟斯卉, 徐云根, 沈卫阳. 棕榈酸曲安奈德中未知杂质的鉴定[J]. 中国药学(英文版), 2022, 31(4): 270-278.
[3]	董馨, 王弘, 马飞祥, 高建萍, 陈世忠, 薛培凤. 基于在线HPLC-自由基清除检测-ESI-IT-TOF-MSn技术的蓝刺头抗氧化成分筛选及其构效关系研究[J]. 中国药学(英文版), 2021, 30(4): 267-279.
[4]	卢紫娟, 贾岩, 邢婕, 肖淑贤, 王玉龙, 秦文杰, 秦雪梅, 李震宇. 基于ITS/ITS2和HPLC指纹图谱技术的款冬花质量评价[J]. 中国药学(英文版), 2021, 30(1): 58-68.
[5]	杨红帅, 刘秋怡, 殷卫东, 解满江, 吉翔, 邵双宇, 梁鸿, 屠鹏飞, 张庆英. 酸枣仁和滇枣仁的HPLC指纹图谱分析及鉴别[J]. 中国药学(英文版), 2020, 29(4): 252-259.
[6]	贾玮娟, 陈世忠, 孙建华, 白宗利, 黄亚卓, 张元宽, 王弘. 基于HPLC特征图谱与指纹图谱分析的中药猪苓质量评价研究[J]. 中国药学(英文版), 2020, 29(12): 896-907.
[7]	杨秀伟, 张友波, 徐嵬. 静脉和灌胃给予大鼠茴香酸对羟基苯乙酯的RP-HPLC法测定和药代动力学研究[J]. 中国药学(英文版), 2020, 29(11): 804-812.
[8]	张雯, 段康飞, 尚明英, 关锰, 李得运, 白宗利, 乐志勇, 蔡少青. 采收和炮制对麻黄中五种生物碱含量的影响[J]. 中国药学(英文版), 2019, 28(5): 339-347.
[9]	欧阳文鹃, 张亚兰, 徐平声, 戴智勇, 马虹英, 秦群. 国产注射用甲磺酸帕珠沙星在健康人体的药代动力学研究[J]. 中国药学(英文版), 2019, 28(1): 40-48.
[10]	仝令坤, 王弘, 张笑天, 郭宁宁, 韩雅, 王岱东, 陈世忠. 中药罗布麻叶中化学成分的LC/MS分析及其最佳采收期的研究[J]. 中国药学(英文版), 2018, 27(4): 251-262.
[11]	Agha Zeeshan Mirza. HPLC-UV method for simultaneous determination of irbesartan, candesartan, gliquidone and pioglitazone in formulations and in human serum[J]. 中国药学(英文版), 2018, 27(4): 273-280.
[12]	陈燕芬, 孙萌, 张世喜, 程泽能, 胡高云, 朱曲波. 高效液相色谱法定量测定美氟尼酮(吡非尼酮的新衍生物)的浓度及其在肝微粒体中的初始药代动力学研究[J]. 中国药学(英文版), 2018, 27(3): 193-200.
[13]	黄丹, 张道林, 王娜娜, 蒋心惠. 高效液相色谱法分离测定恩替卡韦光学异构体[J]. 中国药学(英文版), 2018, 27(3): 201-208.
[14]	潘峰, 吴卫, 董品利, 胡博, 官玲亮, 舒玲. HPLC-DAD法对不同生长年限瓦布贝母10种核苷和碱基含量的测定[J]. 中国药学(英文版), 2017, 26(5): 346-354.
[15]	曹思思, 邓阳, 蔡骅琳, 侯振彦, 颜苗, 张毕奎. HPLC-MS/MS法研究氨氯地平片在健康人体内的药动学和生物等效性[J]. 中国药学(英文版), 2017, 26(4): 291-297.