Safety Monitoring

Determination of nifedipine illegally adulterated in food and health foods by UPLC-MS/MS*

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  • 1. National Institute of Food and Drug Control, Beijing 100050, China;
    2. China national Center for Food Safety Risk Assessment, Beijing 100022, China

Received date: 2021-03-24

  Online published: 2024-06-24

Abstract

Objective: To establish an UPLC-MS/MS method for simultaneous determination of nifedipine and its two degradation products(dehydro nifedipine and dehydronitroso nifedipine) added illegally in food and health food. Methods: Samples were extracted by acetonitrile aqueous solution containing 5% formic acid. The analysis was performed on C18(50 mm×2.1 mm,1.8 μm)column with gradient elution using a mobile phase of 0.1% aqueous formic acid(2 mmol·L-1 ammonium formate)and acetonitrile at 0.4 mL·min-1. Mass spectrometry acquisition was done in the positive ion mode and analytes were detected in the MRM mode. Results: Three chemical components could be separately well and have a good linear relationship in 2-100 μg·L-1 range. The average recovery rates of low,medium and high concentration were 90.9%-103.0% with the RSD of 1.2%-6.1%. The detection limits and quantitation limits of each component in various matrices were lower than 0.05 mg·kg-1 and 0.1 mg·kg-1, respectively. Conclusion: The developed method verified by the methodology is precise, sensitive, accurate, which therefore can be applied for the analysis of illegally added in food health food.

Cite this article

NING Xiao, JING Shao-ming, DONG Zhe, ZHAO Yun-feng, CAO Jin . Determination of nifedipine illegally adulterated in food and health foods by UPLC-MS/MS*[J]. Chinese Journal of Pharmaceutical Analysis, 2022 , 42(5) : 821 -830 . DOI: 10.16155/j.0254-1793.2022.05.11

References

[1] PAPICH MG. Nifedipine[M].4th Ed. Philadelphia: W.B. Saunders Company,2016: 563
[2] EASTERLIN T, MUNDLE S, BRACKEN H, et al. Oral antihypertensive regimens (nifedipine retard, labetalol, and methyldopa) for management of severe hypertension in pregnancy: an open-label, randomised controlled trial[J].Obstet Gynecol Surv, 2020, 75(2):81
[3] 赖敏, 帅维, 李萍,等. 口舌下含服硝苯地平控释片快速降压作用的初步观察[J].中华高血压杂志, 2019, 27(5): 463
LAI M, SHUAI W, LI P, et al. Preliminary observation on rapid hypotensive effect of nifedipine controlled-release tablets taken under tongue[J].Chin J Hypertens, 2019, 27(5): 463
[4] 陈立群, 曹云飞. UPLC-MS法测定降压类中成药和保健食品中非法添加硝苯地平的含量[J].黑龙江医药, 2016, 29(1): 3
CHEN LQ,CAO YF. Content determination of nifedipine illegally added in antihypertensive Chinese patent drug and health food by UPLC-MS[J].Heilongjiang Med J, 2016, 29(1): 3
[5] 陈国权, 雷毅.高效液相色谱法测定降血压类健康产品中的6种二氢吡啶类成分[J].理化检验(化学分册), 2016, 52(7): 770
CHEN GQ,LEI Y. HPLC determination of 6 dihydropyridine chemicals in health products for antihypertension[J].Phys Test Chem Anal(Part B:Chem Anal), 2016, 52(7): 770
[6] 张圳锋, 林桂娥, 陈少文. 分析不同剂型硝苯地平治疗高血压的临床效果[J].北方药学, 2018,15(8): 131
ZHANG ZF, LIN GE, CHEN SW. To analyze the clinical effect of different dosage forms of nifedipine in the treatment of hypertension[J].J North Pharm, 2018, 15(8): 131
[7] YUSUF D, CHRISTY J, OWEN D, et al. A case report of nifedipine-induced hepatitis with jaundice[J].BMC Res Notes, 2018, 11(1):228
[8] 张玲丽. UV/H2O2对水中诺氟沙星和硝苯地平的降解研究[D].济南:山东师范大学,2017
ZHANG LL. Degradation of Norfloxacin and Nifedipine in Water by UV/H2O2[D].Jinan:Shandong Normal University, 2017
[9] NIKITINA A, YAROSHENKO I, SIDOROVA A. Development of a HPLC-MS/MS method for the simultaneous determination of nifedipine and lidocaine in human plasma[J].J Pharm Biomed Anal, 2016, 131:13
[10] HU J, ZENG L, HE L, et al. Multiwalled carbon nanotubes-dispersive solid-phase extraction coupled with UPLC-ESI-MS-MS for simultaneous determination of 10 illegal adulterants in antihypertensive functional foods[J].J Chromatogr Sci, 2016, 54(5):847
[11] GALAN RC, GONZÁLEZÁJ, VALLS RM. Method development and validation study for quantitative determination of nifedipine and related substances by ultra-high-performance liquid chromatography[J].Biomed Chromatogr, 2015, 29(2):233
[12] YENDLURI R, OTTO DP, DEVILLIERS MM, et al. Application of halloysite clay nanotubes as a pharmaceutical excipient[J].Int J Pharm, 2017, 521(1-2):267
[13] THEIL F, ANANTHARAMAN S, KYEREMATENG SO, et al. Frozen in time: kinetically stabilized amorphous solid dispersions of nifedipine stable after a quarter century of storage[J].Mol Pharm, 2017, 14(1):183
[14] HERNANDEZ DT, RAVELA N, SANCHEZ RS, et al. Evaluation of different light conditions in the working environment for handling photosensitive and thermolabile compounds[J].J AOAC Int, 2015, 98(6):1491
[15] FRANZE S, MUSAZZI UM, MINGHETTI P, et al. Drug-in-micelles-in-liposomes (DiMiL) systems as a novel approach to prevent drug leakage from deformable liposomes[J].Eur J Pharm Sci, 2019, 130:27
[16] OZAKAR E, CETIN M, ATES O, et al. Nifedipine-loaded polymeric nanoparticles:preparation and in vitro characterization[J].Pak J Pharm Sci, 2019, 32(2):547
[17] GIBBS NK, TRAYNOR NJ, JOHNSON BE, et al. In vitro phototoxicity of nifedipine: sequential induction of toxic and non-toxic photoproducts with UVA radiation[J].J Photochem Photobiol B, 1992, 13(3-4):275
[18] ODANI N, MOHAN S, KATO E, et al. Determining the effect of photodegradation on film coated nifedipine tablets with terahertz based coating thickness measurements[J].Eur J Pharm Biopharm, 2019, 145:35
[19] FUJIMOTO Y, HIRAI N, TAKATANI N, et al. Photostable solid dispersion of nifedipine by porous calcium silicate[J].Chem Pharm Bull (Tokyo),2016,64(8):1218
[20] SCHMID BJ, PERRY HE, IDLE JR. Determination of nifedipine and its three principal metabolites in plasma and urine by automated electron-capture capillary gas chromatography[J].J Chromatogr B: Biomed Sci Appl, 1988, 425:107
[21] PARK JW, CHOI JS. Role of kaempferol to increase bioavailability and pharmacokinetics of nifedipine in rats [J].Chin J Nat Med, 2019, 17(9):690
[22] MATUSZEWSKI BK, CONSTANZER ML, CHAVEZ CM. Strategies for the assessment of matrix effect in quantitative bioanalytical methods based on HPLC-MS/MS [J].Anal Chem, 2003, 75(13):3019
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