The development of analytical procedures using ICP-OES and ICP-MS for the analysis of trace metals in pharmaceutical formulations
New regulations regarding elemental impurities in pharmaceuticals will be implemented in January 2018 and the guidelines include the use of inductively coupled plasma optical emission spectroscopy (ICP-OES) and inductively coupled plasma mass spectrometry (ICP-MS). In this work, a method using each...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
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University of Huddersfield Press
2017-12-01
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| Series: | British Journal of Pharmacy |
| Subjects: | |
| Online Access: | https://www.bjpharm.org.uk/article/id/41/ |
| _version_ | 1797821678350237696 |
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| author | Samar Thiab Mark Wainwright Philip Riby |
| author_facet | Samar Thiab Mark Wainwright Philip Riby |
| author_sort | Samar Thiab |
| collection | DOAJ |
| description | New regulations regarding elemental impurities in pharmaceuticals will be implemented in January 2018 and the guidelines include the use of inductively coupled plasma optical emission spectroscopy (ICP-OES) and inductively coupled plasma mass spectrometry (ICP-MS). In this work, a method using each instrument was developed for the analysis of arsenic (As), cadmium (Cd), mercury (Hg), lead (Pb), cobalt (Co), nickel (Ni) and vanadium (V) and validated to meet the international conference of harmonisation (ICH Q3D) guidelines. Liquid and solid samples were prepared using microwave assisted acid digestion method that was developed using reverse aqua regia. The results obtained from the validation showed good linearity (R2>0.995) with low limits of detections (LODs) and limits of quantifications (LOQs). The percentage recoveries for both the standard reference material (SRM) and the spiked samples were between 95-105% with relative standard deviation (RSD) of less than 5. Cold symptoms relief products were purchased and analysed. Levels of Pb and Cd in certain products were found to exceed the permitted daily exposure limit (PDE) when the maximum dose was taken. |
| first_indexed | 2024-03-13T09:57:19Z |
| format | Article |
| id | doaj.art-1e5fa5189cce4d458379f4d8cd5570c5 |
| institution | Directory Open Access Journal |
| issn | 2058-8356 |
| language | English |
| last_indexed | 2024-03-13T09:57:19Z |
| publishDate | 2017-12-01 |
| publisher | University of Huddersfield Press |
| record_format | Article |
| series | British Journal of Pharmacy |
| spelling | doaj.art-1e5fa5189cce4d458379f4d8cd5570c52023-05-23T14:49:08ZengUniversity of Huddersfield PressBritish Journal of Pharmacy2058-83562017-12-012210.5920/bjpharm.2017.12The development of analytical procedures using ICP-OES and ICP-MS for the analysis of trace metals in pharmaceutical formulationsSamar ThiabMark WainwrightPhilip RibyNew regulations regarding elemental impurities in pharmaceuticals will be implemented in January 2018 and the guidelines include the use of inductively coupled plasma optical emission spectroscopy (ICP-OES) and inductively coupled plasma mass spectrometry (ICP-MS). In this work, a method using each instrument was developed for the analysis of arsenic (As), cadmium (Cd), mercury (Hg), lead (Pb), cobalt (Co), nickel (Ni) and vanadium (V) and validated to meet the international conference of harmonisation (ICH Q3D) guidelines. Liquid and solid samples were prepared using microwave assisted acid digestion method that was developed using reverse aqua regia. The results obtained from the validation showed good linearity (R2>0.995) with low limits of detections (LODs) and limits of quantifications (LOQs). The percentage recoveries for both the standard reference material (SRM) and the spiked samples were between 95-105% with relative standard deviation (RSD) of less than 5. Cold symptoms relief products were purchased and analysed. Levels of Pb and Cd in certain products were found to exceed the permitted daily exposure limit (PDE) when the maximum dose was taken.https://www.bjpharm.org.uk/article/id/41/pharmacyicp-msicp-oeselemental impuritiesapsmedicine |
| spellingShingle | Samar Thiab Mark Wainwright Philip Riby The development of analytical procedures using ICP-OES and ICP-MS for the analysis of trace metals in pharmaceutical formulations British Journal of Pharmacy pharmacy icp-ms icp-oes elemental impurities aps medicine |
| title | The development of analytical procedures using ICP-OES and ICP-MS for the analysis of trace metals in pharmaceutical formulations |
| title_full | The development of analytical procedures using ICP-OES and ICP-MS for the analysis of trace metals in pharmaceutical formulations |
| title_fullStr | The development of analytical procedures using ICP-OES and ICP-MS for the analysis of trace metals in pharmaceutical formulations |
| title_full_unstemmed | The development of analytical procedures using ICP-OES and ICP-MS for the analysis of trace metals in pharmaceutical formulations |
| title_short | The development of analytical procedures using ICP-OES and ICP-MS for the analysis of trace metals in pharmaceutical formulations |
| title_sort | development of analytical procedures using icp oes and icp ms for the analysis of trace metals in pharmaceutical formulations |
| topic | pharmacy icp-ms icp-oes elemental impurities aps medicine |
| url | https://www.bjpharm.org.uk/article/id/41/ |
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