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.

中文翻译：

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验证用于测定药用植物和相关药物制剂中的汞、铅、镉和砷的 ICP-MS 方法

描述了使用微波酸性矿化法测定药用植物原料和相关药物制剂中受管制的有毒元素杂质的 ICP-MS 方法的验证。所选的样品制备技术可确保最大程度地将重金属释放到溶液中，而无需使用硝酸完全分解有机基质。使用植物不同部分的样品（即菖蒲根茎、乞丐草本植物和杜松子）评估了该方法的适用性。实验数据用于估计被验证方法的线性、定量限、准确度、重复性和实验室内精密度。标准偏差、变异系数、置信区间、系统误差、Fisher F 标准、和学生 t 标准是根据测量的砷、铅、汞和镉的提取系数计算的。获得的统计参数满足国内外监管指南验证的验收标准。