Validation of an ICP-MS Method for the Determination of Mercury, Lead, Cadmium, and Arsenic in Medicinal Plants and Rela
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Pharmaceutical Chemistry Journal, Vol. 54, No. 9, December, 2020 (Russian Original Vol. 54, No. 9, September, 2020)
VALIDATION OF AN ICP-MS METHOD FOR THE DETERMINATION OF MERCURY, LEAD, CADMIUM, AND ARSENIC IN MEDICINAL PLANTS AND RELATED DRUG PREPARATIONS V. M. Shchukin,1,* E. S. Zhigilei,1 A. A. Erina,1 Yu. N. Shvetsova,1 N. E. Kuz’mina,1 and A. I. Luttseva1 Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 54, No. 9, pp. 57 – 64, September, 2020.
Original article submitted July 17, 2020. 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. Keywords: ICP-MS method, microwave mineralization, heavy metals, analytical procedure validation, linearity, accuracy, repeatability, precision, quantitation limit, calamus rhizomes, beggar-tick herb, juniper berries.
[7, 8]. Elemental toxins of anthropogenic and natural origin are known to affect a whole spectrum of biological systems including cell metabolism disruption, functioning of separate organs, mutations, etc. [9 – 11]. A transition has now occurred from methodology for determining total elemental toxins to that for selective determination of each of the most toxic elements in herbal preparations because of new data reporting the effects of elemental toxins on the human body [12 – 15] and their masking, cumulative, and synergistic effects [16 – 18]. Requirements for selective determination of As, Cd, Hg, and Pb were given in the State Pharmacopoeia XIIIth Ed. [19]. Requirements for selective determination in the State Pharmacopoeia, XIVth Ed. (SP RF 14) [20] were supplemented with the possibility for individual regulation of elemental toxins in various types of MPR and MPP. The calorimetric method used previously in domestic and foreign compendial practice to determine the limiting content was not specific and allowed only the total content of heavy metals and metalloids to be estimated by comparing to a standard. Its main deficiency was the inability to determine if a
Implementation of the state program Development of the Pharmaceutical and Medical Industries (sub
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