Determination of nifedipine concentration in human plasma by LC-MS and its application in pharmacokinetic study

doi:10.5246/jcps.2010.06.063

Abstract

Abstract:

A sensitive and reproducible electro-spray ionization liquid chromatography-mass spectrometry (ESI-LC-MS) method was developed and validated to determine the concentration of nifedipine in human plasma. Following a simple liquid-liquid extraction with methylene chloride, nifedipine and nitrendipine (used as internal standard) were separated on a Diamonsil ODS column (150 mm×4.6 mm, 5 μm) by isocratic elution with acetonitrile-5 mmol/L ammonium acetate (52:48, v/v) at the flow rate of 1 mL/min, and detected by mass spectrometry in the selected ion monitoring (SIM) mode. The pseudomolecular ions [M+Na]⁺(m/z 369.0 for nifedipine and 383.1 for nitrendipine) were selected as the target ions for quantification with fragment electric voltage of 110 V for nifedipine and 100 V for IS. Method validation demonstrated that the developed method had excellent specificity and sensitivity, and acceptable precision and accuracy. Good linearity was achieved over a wide range of (2-600) µg/L (r²>0.998). The plasma samples were stable after storing for more than 14 d and after two freeze-thaw cycles (-20 °C to 25 °C). The method was successfully applied to clinical pharmacokinetic studies of nifedipine.

Key words: Nifedipine, LC-MS, Pharmacokinetics

CLC Number:

R945

Supporting:

Jing Zhang, Hao-Jing Song, Fan-Long Bu, Chun-Min Wei, Gui-Yan Yuan, Xiao-Yan Liu, Ben-Jie Wang, Rui-Chen Guo^* . Determination of nifedipine concentration in human plasma by LC-MS and its application in pharmacokinetic study[J]. , DOI: 10.5246/jcps.2010.06.063.

[1]	Yanfang Yang, Wei Wei, Lei Zhang, Wei Xu, Xiuwei Yang. Simultaneous quantification of 37 constituents in Duliang Pill by UPLC-MS/MS: Application to the pharmacokinetic studies in rat plasma [J]. Journal of Chinese Pharmaceutical Sciences, 2023, 32(7): 560-573.
[2]	Yizheng Sun, Ying Qu, Xiaoyan Liu, Wei Xu, Youbo Zhang. Comparative study on ginsenosides of ginsengs from different regions [J]. Journal of Chinese Pharmaceutical Sciences, 2023, 32(12): 961-970.
[3]	Yingyuan Lu, Mei Zhang, Shengju Yin, Xiaona Dong, Zhiyuan Zhang, Haixu Cheng, Pengfei Tu, Guifang Dou, Yongsheng Che, Zhenghui Xu, Feng Xu, Xian Wang, Chuang Lu, Yaqing Lou, Guoliang Zhang. Epigenetic variants of xenobiotic metabolism affect individual differences in antiepileptic drug 3,4-DCPB pharmacokinetic phenotype [J]. Journal of Chinese Pharmaceutical Sciences, 2023, 32(1): 1-16.
[4]	Xiangfei Jin, Minyue Cheng, Sihui Zhong, Yungen Xu, Weiyang Shen. Identification of unknown impurities in triamcinolone acetonide palmitate [J]. Journal of Chinese Pharmaceutical Sciences, 2022, 31(4): 270-278.
[5]	Yanfang Yang, Yinan Zhang, Youbo Zhang, Xiuwei Yang. Simultaneous quantification of evodiamine, rutaecarpine, and dehydroevodiamine in rat cerebrospinal fluid and cerebral nuclei after oral administration by UPLC-MS/MS [J]. Journal of Chinese Pharmaceutical Sciences, 2022, 31(1): 13-22.
[6]	Yanan Li, Xue Guo, Ye Yuan, Weichong Dong, Xiuling Yang. Determination of free ceftriaxone concentration and its application in predicting lung tissue concentration [J]. Journal of Chinese Pharmaceutical Sciences, 2021, 30(7): 578-589.
[7]	Xiaojiao Li, Shuxin Luan, Hong Zhang, Hongquan Wan, Hong Chen, Chengjiao Liu, Chang Liu, Yanhua Ding. Pharmacokinetics, pharmacodynamics and safety of a single-dose long-acting Risperidone injection in Chinese patients with schizophrenia [J]. Journal of Chinese Pharmaceutical Sciences, 2021, 30(3): 206-217.
[8]	Yan Zhou, Hengwen Song, Zhichao Shao, Bomin Yin, Ximei Fu, Dianyou Xie, Lijun Wei. Preclinical efficacy of a novel cyclin-dependent kinase 9 inhibitor, QHRD107 against acute myeloid leukemia [J]. Journal of Chinese Pharmaceutical Sciences, 2021, 30(2): 146-156.
[9]	Yanfang Liu, Jiashan Zhang, Yunbiao Tang, Hua Huo. Quantification of flupirtine and its active metabolite D-13223 in human plasma by LC-MS/MS: application to a clinical trial of flupirtine maleate capsules in healthy male Chinese volunteers [J]. Journal of Chinese Pharmaceutical Sciences, 2021, 30(10): 822-830.
[10]	Ye Yuan, Bo Yu, Xueqin Zhang, Yanan Li, Shumei Wang. Effects of Zhenyuan capsule on the pharmacokinetics comparison of simvastatin and its active metabolites in rats [J]. Journal of Chinese Pharmaceutical Sciences, 2020, 29(7): 494-503.
[11]	Jin Zhang, Weiwei Lin, Wei Wu, Xianzhong Guo, Pinfang Huang, Xinhua Lin, Zheng Jiao, Changlian Wang. Population pharmacokinetics of vancomycin in Chinese elderly patients and its application for dose individualisation [J]. Journal of Chinese Pharmaceutical Sciences, 2020, 29(4): 260-271.
[12]	Xinyu Chang, Tao Guo, Guiming Guo . Effect of CYP3A4 genetic polymorphisms on pharmacokinetics of tinidazole [J]. Journal of Chinese Pharmaceutical Sciences, 2020, 29(4): 272-279.
[13]	Shengxin Wang, Xiangli Yan, Haozhen Zheng, Jianye Yu, Aiming Yu, Xiao Shen, Lisheng Wang. Pharmacokinetics of different dosage of astragalus membranaceus of buyang huanwu decoction in rats with cerebral ischemic injury by microdialysis combined with LC/MS [J]. Journal of Chinese Pharmaceutical Sciences, 2020, 29(2): 90-101.
[14]	Jingjing Cao, Jun Sun, Shujuan Zhao, Peizhi Ma. Pharmacological and clinical evaluation of a new anti-flu drug, baloxavir marboxil [J]. Journal of Chinese Pharmaceutical Sciences, 2020, 29(10): 729-733.
[15]	Xin Liu, Bo Zhang, Dan Mei, Kai Huang. Rapid and sensitive HPLC-MS/MS method for quantitative determination of isochlorogenic acid B in rat plasma and its application in pharmacokinetic study [J]. Journal of Chinese Pharmaceutical Sciences, 2019, 28(3): 167-173.

Determination of nifedipine concentration in human plasma by LC-MS and its application in pharmacokinetic study

PDF (PC)

Knowledge

Abstract

Cite this article

share this article

References

Related Articles 15

Recommended Articles

Metrics

Comments