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Validation of an ICP-MS Method for the Determination of Mercury, Lead, Cadmium, and Arsenic in Medicinal Plants and Related Drug Preparations

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Pharmaceutical Chemistry Journal Aims and scope

Validation of an ICP-MS method with microwave acidic mineralization for the determination of regulated toxic elemental impurities in medicinal plant raw materials and related drug preparations is described. The selected sample preparation technique ensures the maximum release of heavy metals into solution without completely decomposing the organic matrix using nitric acid. The method applicability was assessed using samples of different parts of plants, i.e., calamus rhizomes, beggar-tick herb, and juniper berries. Experimental data were used to estimate the linearity, limit of quantitation, accuracy, repeatability, and intralaboratory precision of the method being validated. Standard deviations, coefficients of variation, confidence intervals, systematic errors, Fisher F-criteria, and Student t-criteria were calculated based on the measured extraction coefficients of arsenic, lead, mercury, and cadmium. The obtained statistical parameters satisfied the acceptance criteria of the validation according to domestic and foreign regulatory guidelines.

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References

  1. I. Filippova (ed.), Remedium, Zh. Ross. Rinke Lek. Med. Tekh., 7 – 8, 15 – 16 (2016); doi: 10.21518/1561.5936-2016-7-8-15-16.

  2. N. N. Boiko, A. V. Bondarev, and E. T. Zhilyakova, Nauchn. Rezul’t. Biomed. Issled., 3(4), 30 – 38 (2017).

    Google Scholar 

  3. P. Ziarati, N. N. Ziarati, S. Nazeri, et al., Orient. J. Chem., 31(1), 317 – 326 (2015); doi: https://doi.org/10.13005/ojc/310136.

    Article  Google Scholar 

  4. N. K. Glavac, S. Djogo, S. Razic, et al., Arch. Ind. Hygiene Toxicol., 68(3), 236 – 244 (2017); doi: 10.1515/aiht-2017-68-2990.

  5. A. Grejtovsky and R. Pirc, J. Appl. Bot., 74(5)/6, 169 – 174 (2000).

  6. H. Y. Zhan, Y. F. Jiang, J. Yuan, et al., J. Geochem. Explor., 147, 182 – 188 (2014); doi: https://doi.org/10.1016/j.gexplo.2014.10.007.

    Article  CAS  Google Scholar 

  7. S. Bolan, R. Naidu, A. Kunhikrishnan, et al., Sci. Total Environ., 539, 304 – 312 (2016); doi: https://doi.org/10.1016/j.scitotenv.2015.08.124.

    Article  PubMed  CAS  Google Scholar 

  8. M. A. Mikulski, M. D. Wichman, D. L. Simmons, et al., Int. J. Occup. Environ. Health, 23(3), 187 – 192 (2017); doi: https://doi.org/10.1080/10773525.2018.1447880.

    Article  PubMed  CAS  Google Scholar 

  9. M. Youns, J. D. Hoheisel, and T. Efferth, Planta Med., 76(17), 2019 – 2025 (2010); doi: https://doi.org/10.1055/s-0030–1250432.

  10. N. S. Shaban, K. A. Abdou, and N. E.-H. Y Hassan, Beni-suef Univ. J. Basic Appl. Sci., 5(1), 102 – 106 (2016); doi: https://doi.org/10.1016/j.bjbas.2015.10.001.

    Article  Google Scholar 

  11. N. V. Reutova, Ekol. Genet., 13(3), 70 – 75 (2015).

    Google Scholar 

  12. L. Leffers, M. Unterberg, M. Bartel, et al., Toxicology, 305, 109 – 119 (2013); doi: https://doi.org/10.1016/j.tox.2013.01.007.

    Article  PubMed  CAS  Google Scholar 

  13. M. E. Morales, R. S. Derbes, C. M. Ade, et al., PLoS One, 11(3), (2016); doi: https://doi.org/10.1371/journal.pone.0151367.

  14. A. V. Lovinskaya, S. Zh. Kolumbaeva, M. A. Suvorova, et al., Ekol. Genet., 17(2), 69 – 81 (2019).

    Google Scholar 

  15. J. Rodríguez and P. M. Mandalunis, J. Toxicol., 2018, 1 – 11 (2018); doi: https://doi.org/10.1155/2018/4854152.

    Article  CAS  Google Scholar 

  16. Y. H. Choi, H. Hu, B. Mukherjee, et al., Environ. Health Perspect., 120(11), 1544 – 1550 (2012); doi: https://doi.org/10.1289/ehp_1104863.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  17. Q. Zhou, Y. Gu, X. Yue, et al., Mol. Med. Rep., 15(2), 859 – 866 (2017); doi: https://doi.org/10.3892/mmr.2016.6089.

    Article  PubMed  CAS  Google Scholar 

  18. A. Kortenkamp, Environ. Health Perspect., 115 (Suppl. 1), 98 – 105 (2007); doi: https://doi.org/10.1289/ehp.9357.

    Article  PubMed  PubMed Central  Google Scholar 

  19. GPM 1.5.3.0009.15. Determination of heavy metal and arsenic contents in medicinal plant raw material and medicinal plant preparations, SP, XIIIth Ed., Vol. II, Moscow (2015), pp. 420 – 433.

  20. GPM 1.5.3.0009.15 Determination of heavy metal and arsenic contents in medicinal plant raw material and medicinal plant preparations, SP, XIVth Ed., Vol. II, Moscow (2018), pp. 2370 – 2382.

  21. A. M. Thayer, Chem. Eng. News, 91(33), 10 – 13 (2013); http: // cen.acs.org/articles/91/i33/Trace-Metals-Debate.html.

  22. V. Balaram, TrAC, Trends Anal. Chem., 80, 83 – 95 (2016); doi: https://doi.org/10.1016/j.trac.2016.02.001.

  23. R. R. Nageswara and M. V. Talluri, J. Pharm. Biomed. Anal., 43(1), 1 – 13 (2007); doi: https://doi.org/10.1016/j.jpba.2006.07.004.

    Article  Google Scholar 

  24. V. M. Shchukin and E. Yu. Severinova, Usp. Sovrem. Estestvozn., 10, 57 – 62 (2016).

    Google Scholar 

  25. V. M. Shchukin, N. E. Kuz’mina, et al., Vedomosti Nauchn. Tsentra Ekspert. Sredstv Med. Primen., 10(1), 41 – 50 (2020); doi: 10.30895/1919-2919-2020-10-1-41-50.

  26. K. Van Hoecke, C. Catry, and F. Vanhaecke, J. Anal. At. Spectrom., 27(11), 1909 – 1919 (2012); doi: https://doi.org/10.1039/c2ja30128h.

    Article  Google Scholar 

  27. P. Cava-Montesinos, E. Rodenas-Torralba, A. Morales-Rubio, et al., Anal. Chim. Acta, 506(2), 145 – 153 (2004); doi: https://doi.org/10.1016/j.aca.2003.11.023.

    Article  CAS  Google Scholar 

  28. N. V. Yurgel’ (ed.), Guideline for Validation of Procedures for Analysis of Medicines. Methodical Recommendations [in Russian], Sport i Kul’tura – 2000, Moscow (2007).

  29. V. V. Beregovykh, Validation of Analytical Procedures for Drug Manufacturers [in Russian], Literra, Moscow (2008).

  30. GPM. 1.1.0012.15, Validation of analytical procedures, SP XIVth Ed., Vol. 1, Moscow (2018), pp. 276 – 288.

  31. N. A. Vasilenko, M. I. Kharchenko, and A. B. Belova, Handbook of Experimental Study Methods for Drug Development and Quality Review [in Russian], Pero, Moscow (2014).

  32. Elemental impurities – procedures (233), The United States Pharmacopeia 42 The National Formulary 37, United Book Press, Inc., Baltimore, MD (2019).

  33. Heavy metals analysis in herbal drugs and herbal drug preparations (152), European Pharmacopoeia 9.0, Strasbourg (2017).

  34. R. Mohamed, B. H. Zainudin, and A. S. Yaakob, Food Chem., 303, 125392 (2020); doi: https://doi.org/10.1016/j.foodchem.2019.125392.

    Article  PubMed  CAS  Google Scholar 

  35. E. Chevallier, R. Chekri, J. Zinck, et al., J. Food Compos. Anal., 41, 35 – 41 (2015); doi: https://doi.org/10.1016/j.jfca.2014.12.024.

    Article  CAS  Google Scholar 

  36. O. Chahrour, J. Malone, M. Collins, et al., J. Pharm. Biomed. Anal., 145, 84 – 90 (2017); doi: https://doi.org/10.1016/j.jpba.2017.06.045.

    Article  PubMed  CAS  Google Scholar 

Download references

Acknowledgments

The work was performed in the framework of State Task No. 056-00003-20-00 for SCEEMP, Ministry of Health of Russia for applied scientific research (State Acct. No. NIR AAAA-A18-118021590049-0).

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Authors and Affiliations

  1. Scientific Centre for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation, 8 Petrovskii Blvd., Moscow, 127051, Russia

    V. M. Shchukin, E. S. Zhigilei, A. A. Erina, Yu. N. Shvetsova, N. E. Kuz’mina & A. I. Luttseva

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  1. V. M. Shchukin
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  2. E. S. Zhigilei
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  3. A. A. Erina
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  4. Yu. N. Shvetsova
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  5. N. E. Kuz’mina
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  6. A. I. Luttseva
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Correspondence to V. M. Shchukin.

Additional information

Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 54, No. 9, pp. 57 – 64, September, 2020.

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Shchukin, V.M., Zhigilei, E.S., Erina, A.A. et al. Validation of an ICP-MS Method for the Determination of Mercury, Lead, Cadmium, and Arsenic in Medicinal Plants and Related Drug Preparations. Pharm Chem J 54, 968–976 (2020). https://doi.org/10.1007/s11094-020-02306-8

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  • DOI: https://doi.org/10.1007/s11094-020-02306-8

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