An overview of recent applications of inductively coupled plasma-mass spectrometry (ICP-MS) in determination of inorganic impurities in drugs and pharmaceuticals

Rao, R. Nageswara; Talluri, M.V.N. Kumar

doi:10.1016/j.jpba.2006.07.004

Cited by 122 publications

(15 citation statements)

References 79 publications

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“…These ionization sources permit soft ionization and formation of protonated or deprotonated molecules without fragmentation (Souverain, Rudaz, & Veuthey, ). Since then, LC–MS is widely applied in many fields including drug discovery (Wishart, ); pharmacokinetics, pharmaceutical, environmental, and food analyses; impurity profiling (Lim & Lord, ; Nageswara Rao & Kumar Talluri, ); and metabolomics (Aretz & Meierhofer, ). It is noteworthy that the wide applicability and advances in the area of MS owe credit to the ESI technique due to its broad coverage of various analytes (Higashi & Ogawa, ).…”

Section: Introductionmentioning

confidence: 99%

Current trends in isotope‐coded derivatization liquid chromatographic‐mass spectrometric analyses with special emphasis on their biomedical application

El-Maghrabey

Kishikawa

Kuroda

2020

Biomedical Chromatography

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Currently, LC–MS has various applications in different areas such as metabolomics, pharmacokinetics, and pathological studies. Yet, matrix effects resulting from co‐existing constituents remain a major problem for LC–MS [or LC–tandem mass spectrometry (LC–MS/MS)]. Moreover, technical problems and instrumental drifts may lead to ion abundance variance. Thus, an internal standard (IS) is required to guarantee the accuracy and precision of the method. Because of their limited number, isotope‐coded derivatization (ICD) has been recently introduced to overcome this problem. For ICD, a stable heavy isotope‐coded moiety is used for labeling the standard or the control sample and the formed products can act as ISs. A light form of the reagent is used for labeling the sample. Then, both are mixed and analyzed by LC–MS(/MS). This strategy permits the identification of different unknown analytes including potential metabolites and disease biomarkers. All these attributes lead to persistent growth in the applications of ICD LC–MS(/MS) in various biomedical branches. In this article we review the ICD methods published in the last eight years for biomedical applications as well as briefly summarize other applications for environmental and food analyses as some of their used ICD reagents were further applied for analyzing biological specimens or have the potential for that.

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Section: Introductionmentioning

confidence: 99%

Current trends in isotope‐coded derivatization liquid chromatographic‐mass spectrometric analyses with special emphasis on their biomedical application

El-Maghrabey

Kishikawa

Kuroda

2020

Biomedical Chromatography

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“…Studies related to the toxicological analyses of metallic impurities in pharmaceuticals (drugs) is an important issue but there is a lack of refereed literature around the safety of teething remedies from herbal origin related to toxic metals impurities. In this article, the unwanted toxicological effects by which any benefit from their administration may be outweighed [1]. Metal impurities in pharmaceuticals may arise from several sources, including, especially, [2]: residual catalysts that were added intentionally in synthesis metal reagent residues;…”

Section: Introductionmentioning

confidence: 99%

Toxicological analysis of Pb and Cd by ET AAS in local anaesthetics for teething (teething gels) based on herbs available in Polish pharmacies

Jurowski

Krośniak

Fołta

et al. 2019

Journal of Trace Elements in Medicine and Biology

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425 577 levels of Pb and Cd were measured in samples of local anaesthetics for teething (gels) based on herbs. This article was motivated by the fact that Pb and Cd are relevant toxic metals that may cause an adverse effect in babies even at low levels. Additional justifications were (1) the insufficient control of metal impurities in teething gels, (2) the lack of sufficient validation steps and (3) the inadequate sensitivity of applied analytical techniques. The aim of this article was a qualitative and quantitative analysis of Pb and Cd in the most popular and available local anaesthetic for teething (teething gels) based on herbs (n = 5) available in Poland. Metals were determined by ET AAS (electrothermal atomization atomic absorption spectrometry), after digestion in a microwave unit using concentrated nitric acid. It was observed that all samples contained Pb and Cd. The levels of Pb and Cd as impurities (independently of the producer and declared composition) are similar. The concentrations ofPb and Cd, at ng/day levels, to which the user is exposed at daily doses meet the standards of the directive ICH Q3D.

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“…Toxic metals in pharmaceuticals, such as lead and cadmium, pose serious health hazards, even at very low doses. 2 Lead exposure may cause cardiovascular effects, increased blood pressure and incidence of hypertension, decreased kidney function and reproductive problems, in both men and women [3][4] , while cadmium is a human carcinogen associated to serious health hazard risks. Experimental and epidemiological evidence strongly suggest that the biological half-life of this element in the body is extremely high, of approximately 10 years or more.…”

Section: Introductionmentioning

confidence: 99%

“…This method is non-spe ifi , less se siti e, ti e-consuming and less accurate. 2 In 2014, the United States Pharmacopeia (USP) proposed several changes to the methods used for the determination of elemental impurities. New limits for inorganic contaminants have been proposed by USP chapters 232 (limits) 8 and 233 (procedures) 9 , as well as by chapter 5.20 of the European Medicines Agency (EMA).…”

Section: Introductionmentioning

confidence: 99%

Evaluation of the Elemental Impurities of the Drug Captopril Marketed Commercialized in Rio de Janeiro, Brazil

Santos

Iozzi²,

Neto³

et al. 2018

Rev. Virtual Quim.

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Avaliação das Impurezas Elementares do Medicamento Captopril Comercializadas na Cidade do Rio de Janeiro, Brasil Resumo: O objetivo desse trabalho foi avaliar e validar metodologia analítica para determinar impurezas elementares em IFAs e produto final de captopril, tendo como base as novas diretrizes da Farmacopeia Americana. As técnicas escolhidas para este fim foram a espectrometria de emissão óptica com plasma indutivamente acoplado (ICP OES) e a espectrometria de absorção atômica com forno de grafite (GF AAS). Os resultados indicam que os métodos possuem sensibilidade, precisão (1.5-10%) e exatidão (86-120%) adequadas para avaliar os elementos inorgânicos nas amostras desejadas. Todas as amostras analisadas apresentaram resultados inferiores ao limite de quantificação das técnicas utilizadas para maioria dos elementos, com exceção do ferro que apresentou resultados superiores ao limite de quantificação da técnica ICP OES (10µg L-1).

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An overview of recent applications of inductively coupled plasma-mass spectrometry (ICP-MS) in determination of inorganic impurities in drugs and pharmaceuticals

Cited by 122 publications

References 79 publications

Current trends in isotope‐coded derivatization liquid chromatographic‐mass spectrometric analyses with special emphasis on their biomedical application

Current trends in isotope‐coded derivatization liquid chromatographic‐mass spectrometric analyses with special emphasis on their biomedical application

Toxicological analysis of Pb and Cd by ET AAS in local anaesthetics for teething (teething gels) based on herbs available in Polish pharmacies

Evaluation of the Elemental Impurities of the Drug Captopril Marketed Commercialized in Rio de Janeiro, Brazil

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