A new ultrasound-assisted microextraction for elemental impurities determination in tablets by ICP-MS according to USP chapters 232 and 233

被引:2
作者
Noronha, Igor Forattini Prates C. [1 ]
Pinheiro, Fernanda C. [1 ]
Nascentes, Clesia C. [1 ]
机构
[1] Univ Fed Minas Gerais, Dept Chem, ICEX, Ave Presidente Antonio Carlos, 6627, BR-31270901 Belo Horizonte, MG, Brazil
关键词
Cup horn; ICP-MS; Sample preparation; Tablets; Quality control; ACTIVE PHARMACEUTICAL INGREDIENTS; SPECTROMETRY; EXTRACTION; PRODUCTS;
D O I
10.1016/j.talanta.2023.125604
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
Along with the United States Pharmacopeia (USP) chapters 232 and 233 regarding elemental impurities in pharmaceutical products, new challenges have been imposed in terms of sample preparation procedures prior to inductively coupled plasma mass spectrometry analysis, considering the matrix complexities. As so, a new microextraction procedure assisted by ultrasound using a cup-horn sonoreactor, minimal reactants, and sample was proposed and validated according to USP. The procedure was optimized with samples of milled tablets and 3 different acid mixtures (HNO3, 3HNO(3):1HCl, and 9HNO(3):1HF) and it was compared with microwave-assisted acid digestion. In the validation step, recoveries ranging from 85 to 120 % and RSD below 10 % were obtained for 22 analytes (except Ag and Pt) with satisfactory linearity and good sensitivity. The method was then applied for 37 samples of antidepressants, which presented trace levels of As, Ba, Cd, Co, Cr, Cu, Ni, Pb, Pd, Sn, and V.
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页数:9
相关论文
共 37 条
[1]   Green miniaturized technologies in analytical and bioanalytical chemistry [J].
Agrawal, Arpana ;
Kecili, Rustem ;
Ghorbani-Bidkorbeh, Fatemeh ;
Hussain, Chaudhery Mustansar .
TRAC-TRENDS IN ANALYTICAL CHEMISTRY, 2021, 143
[2]   Recent advances in the determination of elemental impurities in pharmaceuticals - Status, challenges and moving frontiers [J].
Balaram, V. .
TRAC-TRENDS IN ANALYTICAL CHEMISTRY, 2016, 80 :83-95
[3]   Determination of elemental impurities in pharmaceutical products and related matrices by ICP-based methods: a review [J].
Barin, Juliano S. ;
Mello, Paola A. ;
Mesko, Marcia F. ;
Duarte, Fabio A. ;
Flores, Erico M. M. .
ANALYTICAL AND BIOANALYTICAL CHEMISTRY, 2016, 408 (17) :4547-4566
[4]   Determination of toxic elements in tricyclic active pharmaceutical ingredients by ICP-MS: a critical study of digestion methods [J].
Barin, Juliano S. ;
Tischer, Bruna ;
Picoloto, Rochele S. ;
Antes, Fabiane G. ;
da Silva, Fabiana E. B. ;
Paula, Favero R. ;
Flores, Erico M. M. .
JOURNAL OF ANALYTICAL ATOMIC SPECTROMETRY, 2014, 29 (02) :352-358
[5]   A fast ultrasound-assisted extraction procedure for trace elements determination in hair samples by ICP-MS for forensic analysis [J].
Batista, Bruno Lemos ;
Rodrigues, Jairo Lisboa ;
de Oliveira Souza, Vanessa Cristina ;
Barbosa, Fernando, Jr. .
FORENSIC SCIENCE INTERNATIONAL, 2009, 192 (1-3) :88-93
[6]   Methods for the determination of platinum group elements originating from the abrasion of automotive catalytic converters [J].
Bencs, L ;
Ravindra, K ;
Van Grieken, R .
SPECTROCHIMICA ACTA PART B-ATOMIC SPECTROSCOPY, 2003, 58 (10) :1723-1755
[7]   Ultrasound-assisted pretreatment of solid samples in the context of green analytical chemistry [J].
Bendicho, C. ;
De La Calle, I. ;
Pena, F. ;
Costas, M. ;
Cabaleiro, N. ;
Lavilla, I. .
TRAC-TRENDS IN ANALYTICAL CHEMISTRY, 2012, 31 :50-60
[8]   Microwave-assisted digestion methods: towards greener approaches for plasma-based analytical techniques [J].
Bizzi, C. A. ;
Pedrotti, M. F. ;
Silva, J. S. ;
Barin, J. S. ;
Nobrega, J. A. ;
Flores, E. M. M. .
JOURNAL OF ANALYTICAL ATOMIC SPECTROMETRY, 2017, 32 (08) :1448-1466
[9]  
Brazil ANVISA, 1998, OrdinanceNo.31, of January 13
[10]  
Cabaleiro N, 2014, MINIATURIZATION IN SAMPLE PREPARATION, P308