A direct LA-ICP-MS screening of elemental impurities in pharmaceutical products in compliance with USP and ICH-Q3D

0518566 - MBÚ 2020 RIV NL eng J - Článek v odborném periodiku
Pluháček, Tomáš - Ručka, Michael - Maier, Vítězslav
A direct LA-ICP-MS screening of elemental impurities in pharmaceutical products in compliance with USP and ICH-Q3D.
Analytica Chimica Acta. Roč. 1078, OCT 31 (2019), s. 1-7. ISSN 0003-2670. E-ISSN 1873-4324
Grant CEP: GA MŠMT(CZ) LO1509
Institucionální podpora: RVO:61388971
Klíčová slova: Elemental impurities * Inductively coupled plasma * Mass spectrometry
Obor OECD: Microbiology
Impakt faktor: 5.977, rok: 2019
Způsob publikování: Omezený přístup
https://www.sciencedirect.com/science/article/pii/S000326701930710X?via%3Dihub

The novel laser ablation inductively coupled plasma mass spectrometry methodology for the rapid screening of elemental impurities in solid pharmaceutical samples with the daily dose less than 2.0 g has been developed in accordance with requirements of established USP < 232/233 > chapters and ICH-Q3D guideline. The LA-ICP-MS methodology covering the determination of Cd, Pb, As, Hg, Co, V, Ni, Tl, Au, Pd, Ir, Os, Rh, Ru, Se, Ag, Pt was successfully validated in terms of linearity, limit of quantification, accuracy, precision, intermediate precision, specificity and range. Moreover, the presented 'in-house' matrix-matched standards preparation methodology helps to overcome crucial analytical problem connected with unavailability of commercial certified matrix-matched reference material suitable for the direct elemental impurities analysis in various kinds of solid pharmaceutical products. A two step homogeneity study of prepared matrix-matched calibration standards is also reported to investigate the homogeneity of distribution of elemental impurities and internal standards across the pressed pellet. The validated LA-ICP-MS method was applied on analysis of several types of solid pharmaceutical samples (active pharmaceutical ingredients, excipients, placebo and final drug products). The proposed method allowed the accurate, precise and fast screening of elemental impurities without necessity of time and labour consuming solutions preparation and thus it can be used in routine practice as an alternative to conventional ICP-MS or ICP-OES for the rapid quality control of different stages of pharmaceutical production.
Trvalý link: http://hdl.handle.net/11104/0303674