From the Limit Test for Trace Elements Control to the Elemental Impurities Analysis by Inductively Coupled Plasma Optical Emission Spectrometry: Application on Six Samples of Metronidazole API
Introduction: The objective of this work was to control the inorganic impurities by the trace elements and sulfuric ashs limit tests and to analyze the elemental impurties by Inductively Coupled Plasma Optical Emission Spectrometry (ICP OES) wich is a novel method based on security data in six sampl...
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| Format: | Article |
| Language: | English |
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Elsevier
2022-12-01
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| Series: | Journal of Trace Elements and Minerals |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2773050622000167 |
| _version_ | 1811178219284463616 |
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| author | Derouicha Matmour Abir Bouaffad Yassine Merad Nassima Hamdi Ziani |
| author_facet | Derouicha Matmour Abir Bouaffad Yassine Merad Nassima Hamdi Ziani |
| author_sort | Derouicha Matmour |
| collection | DOAJ |
| description | Introduction: The objective of this work was to control the inorganic impurities by the trace elements and sulfuric ashs limit tests and to analyze the elemental impurties by Inductively Coupled Plasma Optical Emission Spectrometry (ICP OES) wich is a novel method based on security data in six samples of Metronidazole API, collected from six pharmaceutical industries installed in Algeria. Materials and Methods: For the trace elements and sulfuric ashs limit tests, a muffle furnace and a sand bath were used for samples calcination and each sample was processed according to the limit tests of European Pharmacopoeia eighth edition (Eur Ph 8 th ed). For the elemental impurities analysis, an ICP OES device was used for analysis of trace elements in diverse samples and each sample was processed according to the new procedures of American Pharmacopoeia USP 40-NF 35. Results: The results of trace elements and sulfuric ashs limit tests showed that all samples were conform except M1 sample wich contained more than 20 ppm of trace elements. The ICP OES elemental impurities analysis showed that the content of class 1 elements (Cd, Pb, As and Hg) and class 3 elements (Cu, Sn and Cr) of all samples was in the required limits. The content of class 2 elements (Co, Ni and Ag) was in the required limits in all samples except M3 sample which had Nickel content (3.5 ppm) exceeded the authorized limit for the parenteral route (2 ppm). Knowing that Nickel interferes very weakly with Osmium, this may be explained by the fact that this sample was intended to be put into oral forms. Conclusion: The highlighting of Nickel impurity exceeding safety standards confirm that trace elements test is neither specific nor exact, so it's recommended to manufacturers and quality control laboratories to apply the new procedures based on safety data which are well described in the new chapters (232) and (233) of USP or the general chapter 2.4.20 of Eur Ph. |
| first_indexed | 2024-04-11T06:15:55Z |
| format | Article |
| id | doaj.art-0a112fda98e9452e898f01c30751bcb1 |
| institution | Directory Open Access Journal |
| issn | 2773-0506 |
| language | English |
| last_indexed | 2024-04-11T06:15:55Z |
| publishDate | 2022-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Journal of Trace Elements and Minerals |
| spelling | doaj.art-0a112fda98e9452e898f01c30751bcb12022-12-22T04:41:03ZengElsevierJournal of Trace Elements and Minerals2773-05062022-12-012100017From the Limit Test for Trace Elements Control to the Elemental Impurities Analysis by Inductively Coupled Plasma Optical Emission Spectrometry: Application on Six Samples of Metronidazole APIDerouicha Matmour0Abir Bouaffad1Yassine Merad2Nassima Hamdi Ziani3Therapeutic and Pharmaceutical Chemistry Laboratory, Pharmacy Department, Faculty of Medecine, University of Sidi Bel-Abbes, 22000, Algeria; Central Laboratory, University Hospital Center of Sidi Bel-Abbes, 22000, Algeria; Corresponding author.Quality Control Laboratory, WanyLab, Algiers, 16002, AlgeriaCentral Laboratory, University Hospital Center of Sidi Bel-Abbes, 22000, AlgeriaQuality Control Laboratory, WanyLab, Algiers, 16002, AlgeriaIntroduction: The objective of this work was to control the inorganic impurities by the trace elements and sulfuric ashs limit tests and to analyze the elemental impurties by Inductively Coupled Plasma Optical Emission Spectrometry (ICP OES) wich is a novel method based on security data in six samples of Metronidazole API, collected from six pharmaceutical industries installed in Algeria. Materials and Methods: For the trace elements and sulfuric ashs limit tests, a muffle furnace and a sand bath were used for samples calcination and each sample was processed according to the limit tests of European Pharmacopoeia eighth edition (Eur Ph 8 th ed). For the elemental impurities analysis, an ICP OES device was used for analysis of trace elements in diverse samples and each sample was processed according to the new procedures of American Pharmacopoeia USP 40-NF 35. Results: The results of trace elements and sulfuric ashs limit tests showed that all samples were conform except M1 sample wich contained more than 20 ppm of trace elements. The ICP OES elemental impurities analysis showed that the content of class 1 elements (Cd, Pb, As and Hg) and class 3 elements (Cu, Sn and Cr) of all samples was in the required limits. The content of class 2 elements (Co, Ni and Ag) was in the required limits in all samples except M3 sample which had Nickel content (3.5 ppm) exceeded the authorized limit for the parenteral route (2 ppm). Knowing that Nickel interferes very weakly with Osmium, this may be explained by the fact that this sample was intended to be put into oral forms. Conclusion: The highlighting of Nickel impurity exceeding safety standards confirm that trace elements test is neither specific nor exact, so it's recommended to manufacturers and quality control laboratories to apply the new procedures based on safety data which are well described in the new chapters (232) and (233) of USP or the general chapter 2.4.20 of Eur Ph.http://www.sciencedirect.com/science/article/pii/S2773050622000167Toxic elementsInorganic impuritiesICP OESPlasma-based techniqueDrugs |
| spellingShingle | Derouicha Matmour Abir Bouaffad Yassine Merad Nassima Hamdi Ziani From the Limit Test for Trace Elements Control to the Elemental Impurities Analysis by Inductively Coupled Plasma Optical Emission Spectrometry: Application on Six Samples of Metronidazole API Journal of Trace Elements and Minerals Toxic elements Inorganic impurities ICP OES Plasma-based technique Drugs |
| title | From the Limit Test for Trace Elements Control to the Elemental Impurities Analysis by Inductively Coupled Plasma Optical Emission Spectrometry: Application on Six Samples of Metronidazole API |
| title_full | From the Limit Test for Trace Elements Control to the Elemental Impurities Analysis by Inductively Coupled Plasma Optical Emission Spectrometry: Application on Six Samples of Metronidazole API |
| title_fullStr | From the Limit Test for Trace Elements Control to the Elemental Impurities Analysis by Inductively Coupled Plasma Optical Emission Spectrometry: Application on Six Samples of Metronidazole API |
| title_full_unstemmed | From the Limit Test for Trace Elements Control to the Elemental Impurities Analysis by Inductively Coupled Plasma Optical Emission Spectrometry: Application on Six Samples of Metronidazole API |
| title_short | From the Limit Test for Trace Elements Control to the Elemental Impurities Analysis by Inductively Coupled Plasma Optical Emission Spectrometry: Application on Six Samples of Metronidazole API |
| title_sort | from the limit test for trace elements control to the elemental impurities analysis by inductively coupled plasma optical emission spectrometry application on six samples of metronidazole api |
| topic | Toxic elements Inorganic impurities ICP OES Plasma-based technique Drugs |
| url | http://www.sciencedirect.com/science/article/pii/S2773050622000167 |
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