Application of ICH Guidelines for the Assessment and Control of Elemental Impurities in Parecoxib Sodium by Graphite-Digestion and ICP-MS
Parecoxib sodium is a widely used parenteral cyclooxygenase 2 selective inhibitor to relieve acute postoperative pain following gynecologic laparotomy surgery. To ensure the quality of the drug, a detailed quality specification is indispensable. Nevertheless, it is unavoidable to introduce inorganic...
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| Format: | Article |
| Language: | English |
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Wiley
2022-01-01
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| Series: | International Journal of Analytical Chemistry |
| Online Access: | http://dx.doi.org/10.1155/2022/9299416 |
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| author | Yajie Hao Guang Yin Xuemei Wang Zhenglei Jiang Guimin Zhang Zhong Feng Qinyong Sun |
| author_facet | Yajie Hao Guang Yin Xuemei Wang Zhenglei Jiang Guimin Zhang Zhong Feng Qinyong Sun |
| author_sort | Yajie Hao |
| collection | DOAJ |
| description | Parecoxib sodium is a widely used parenteral cyclooxygenase 2 selective inhibitor to relieve acute postoperative pain following gynecologic laparotomy surgery. To ensure the quality of the drug, a detailed quality specification is indispensable. Nevertheless, it is unavoidable to introduce inorganic impurities during the drug preparation process and how to assess and control them matters. This study proposed an analytical procedure for the determination of elemental impurities (Cd, Pb, As, Hg, Co, V, Ni, Li, Sb, and Cu) in parecoxib sodium, where an easier and safer digestion protocol, graphite digestion, combined with an inductively coupled plasma-mass spectrometer (ICP-MS) was adopted when compared with microwave digestion. Moreover, the study also discussed whether should they be listed in specification to comply with ICH Q3D guidelines after test of process validation batches. Limit of quantitation (LOQ) of the above elemental impurities reached to 0.05, 0.125, 0.375, 0.075, 0.125, 0.25, 0.5, 6.25, 2.25 and 7.5 ppm, respectively, and recovery in accuracy item ranged from 90.2% to 129.9%, reflecting a sensitive and accurate method. |
| format | Article |
| id | doaj-art-7d92dbc9189a4f6586f9bba3f486924f |
| institution | Kabale University |
| issn | 1687-8779 |
| language | English |
| publishDate | 2022-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | International Journal of Analytical Chemistry |
| spelling | doaj-art-7d92dbc9189a4f6586f9bba3f486924f2025-02-03T01:21:02ZengWileyInternational Journal of Analytical Chemistry1687-87792022-01-01202210.1155/2022/9299416Application of ICH Guidelines for the Assessment and Control of Elemental Impurities in Parecoxib Sodium by Graphite-Digestion and ICP-MSYajie Hao0Guang Yin1Xuemei Wang2Zhenglei Jiang3Guimin Zhang4Zhong Feng5Qinyong Sun6Department of International Pharmaceutical R&D CentreDepartment of International Pharmaceutical R&D CentreDepartment of International Pharmaceutical R&D CentreDepartment of International Pharmaceutical R&D CentreDepartment of International Pharmaceutical R&D CentreDepartment of International Pharmaceutical R&D CentreDepartment of International Pharmaceutical R&D CentreParecoxib sodium is a widely used parenteral cyclooxygenase 2 selective inhibitor to relieve acute postoperative pain following gynecologic laparotomy surgery. To ensure the quality of the drug, a detailed quality specification is indispensable. Nevertheless, it is unavoidable to introduce inorganic impurities during the drug preparation process and how to assess and control them matters. This study proposed an analytical procedure for the determination of elemental impurities (Cd, Pb, As, Hg, Co, V, Ni, Li, Sb, and Cu) in parecoxib sodium, where an easier and safer digestion protocol, graphite digestion, combined with an inductively coupled plasma-mass spectrometer (ICP-MS) was adopted when compared with microwave digestion. Moreover, the study also discussed whether should they be listed in specification to comply with ICH Q3D guidelines after test of process validation batches. Limit of quantitation (LOQ) of the above elemental impurities reached to 0.05, 0.125, 0.375, 0.075, 0.125, 0.25, 0.5, 6.25, 2.25 and 7.5 ppm, respectively, and recovery in accuracy item ranged from 90.2% to 129.9%, reflecting a sensitive and accurate method.http://dx.doi.org/10.1155/2022/9299416 |
| spellingShingle | Yajie Hao Guang Yin Xuemei Wang Zhenglei Jiang Guimin Zhang Zhong Feng Qinyong Sun Application of ICH Guidelines for the Assessment and Control of Elemental Impurities in Parecoxib Sodium by Graphite-Digestion and ICP-MS International Journal of Analytical Chemistry |
| title | Application of ICH Guidelines for the Assessment and Control of Elemental Impurities in Parecoxib Sodium by Graphite-Digestion and ICP-MS |
| title_full | Application of ICH Guidelines for the Assessment and Control of Elemental Impurities in Parecoxib Sodium by Graphite-Digestion and ICP-MS |
| title_fullStr | Application of ICH Guidelines for the Assessment and Control of Elemental Impurities in Parecoxib Sodium by Graphite-Digestion and ICP-MS |
| title_full_unstemmed | Application of ICH Guidelines for the Assessment and Control of Elemental Impurities in Parecoxib Sodium by Graphite-Digestion and ICP-MS |
| title_short | Application of ICH Guidelines for the Assessment and Control of Elemental Impurities in Parecoxib Sodium by Graphite-Digestion and ICP-MS |
| title_sort | application of ich guidelines for the assessment and control of elemental impurities in parecoxib sodium by graphite digestion and icp ms |
| url | http://dx.doi.org/10.1155/2022/9299416 |
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