Miniaturized sample preparation strategies for the determination of N-nitrosamines in pharmaceutical products: A comprehensive review

Almir Custodio Batista Junior, Yuri Arrates Rocha, Andrea Rodrigues Chaves
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Abstract

N-Nitrosamines (NAs) are classified as potent mutagenic impurities, raising substantial concerns due to their presence in various consumer products, including pharmaceuticals products. The detection of NAs in valsartan-containing medicines in 2018 led regulatory agencies to establish strict guidelines for permissible levels in drug formulations. The standard-gold analytical techniques for NAs determination have been chromatographic techniques (liquid and gas chromatography) coupled with mass spectrometry system, which present higher sensibility and accuracy for target NAs. However, accurate determination of NAs in medicines remains challenging due to their trace-level concentrations and susceptibility to matrix effects, carryover, and contamination of the analytical instrumentation, emphasizing the need for robust sample preparation strategies. Traditional sample preparation methods, although effective, often involve high consumption of solvents, samples, and extraction phases, along with substantial waste generation. In response, miniaturized sample preparation techniques have emerged as sustainable alternatives, offering reduced solvent usage, minimal sample requirements, and lower energy consumption, all while maintaining analytical performance. These green approaches not only align with sustainable analytical practices but also enhance efficiency and environmental compliance in pharmaceutical analysis. This review provides a comprehensive overview of recent advancements in miniaturized sample preparation strategies for the determination of NAs in pharmaceutical products, highlighting their analytical merits and potential for regulatory adoption.
药品中n -亚硝胺的小型化样品制备方法综述
n -亚硝胺(na)被归类为强致突变杂质,由于其存在于各种消费品中,包括药品,引起了极大的关注。2018年在含有缬沙坦的药物中检测到NAs,导致监管机构制定了严格的药物配方允许含量指导方针。测定NAs的标准金分析技术是色谱技术(液相和气相色谱)与质谱联用技术,对目标NAs具有较高的灵敏度和准确性。然而,药物中NAs的准确测定仍然具有挑战性,因为它们的痕量浓度和对基质效应、携带和分析仪器污染的敏感性,强调需要可靠的样品制备策略。传统的样品制备方法虽然有效,但往往涉及高溶剂,样品和提取相的消耗,以及大量的废物产生。因此,小型化样品制备技术已经成为可持续的替代方案,提供了更少的溶剂使用,最小的样品要求,更低的能源消耗,同时保持分析性能。这些绿色方法不仅与可持续分析实践相一致,而且还提高了药物分析的效率和环境合规性。本文综述了用于测定药品中NAs的小型化样品制备策略的最新进展,强调了它们的分析优点和监管采用的潜力。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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