Fast and Sensitive HPLC-ESI-MS/MS Method for Etoricoxib Quantification in Human Plasma and Application to Bioequivalence Study
Etoricoxib is a non-steroidal anti-inflammatory drug (NSAID) used to treat pain and inflammation. The objective of the current study was to develop a sensitive, fast and high-throughput HPLC-ESI-MS/MS method to measure etoricoxib levels in human plasma using a one-step methanol protein precipitation...
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| Format: | Article |
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MDPI AG
2022-09-01
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| Series: | Molecules |
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| Online Access: | https://www.mdpi.com/1420-3049/27/17/5706 |
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| author | Gabriel Onn Kit Loh Emily Yii Ling Wong Yvonne Tze Fung Tan Siew Chyee Heng Mardiana Saaid Kit Yee Cheah Nurul Diyana Mohd Sali Nair Damenthi Sharon Shi Min Ng Long Chiau Ming Kok Khiang Peh |
| author_facet | Gabriel Onn Kit Loh Emily Yii Ling Wong Yvonne Tze Fung Tan Siew Chyee Heng Mardiana Saaid Kit Yee Cheah Nurul Diyana Mohd Sali Nair Damenthi Sharon Shi Min Ng Long Chiau Ming Kok Khiang Peh |
| author_sort | Gabriel Onn Kit Loh |
| collection | DOAJ |
| description | Etoricoxib is a non-steroidal anti-inflammatory drug (NSAID) used to treat pain and inflammation. The objective of the current study was to develop a sensitive, fast and high-throughput HPLC-ESI-MS/MS method to measure etoricoxib levels in human plasma using a one-step methanol protein precipitation technique. A tandem mass spectrometer equipped with an electrospray ionization (ESI) source operated in a positive mode and multiple reaction monitoring (MRM) were used for data collection. The quantitative MRM transition ions were <i>m/z</i> 359.15 > 279.10 and <i>m/z</i> 363.10 > 282.10 for etoricoxib and IS. The linear range was from 10.00 to 4000.39 ng/mL and the validation parameters were within the acceptance limits of the European Medicine Agency (EMA) and Food and Drug Analysis (FDA) guidelines. The present method was sensitive (10.00 ng/mL with S/N > 40), simple, selective (K prime > 2), and fast (short run time of 2 min), with negligible matrix effect and consistent recovery, suitable for high throughput analysis. The method was used to quantitate etoricoxib plasma concentrations in a bioequivalence study of two 120 mg etoricoxib formulations. Incurred sample reanalysis results further supported that the method was robust and reproducible. |
| first_indexed | 2024-03-10T01:28:36Z |
| format | Article |
| id | doaj.art-49ff2c3873f7480096c6769a22eff21e |
| institution | Directory Open Access Journal |
| issn | 1420-3049 |
| language | English |
| last_indexed | 2024-03-10T01:28:36Z |
| publishDate | 2022-09-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Molecules |
| spelling | doaj.art-49ff2c3873f7480096c6769a22eff21e2023-11-23T13:46:44ZengMDPI AGMolecules1420-30492022-09-012717570610.3390/molecules27175706Fast and Sensitive HPLC-ESI-MS/MS Method for Etoricoxib Quantification in Human Plasma and Application to Bioequivalence StudyGabriel Onn Kit Loh0Emily Yii Ling Wong1Yvonne Tze Fung Tan2Siew Chyee Heng3Mardiana Saaid4Kit Yee Cheah5Nurul Diyana Mohd Sali6Nair Damenthi7Sharon Shi Min Ng8Long Chiau Ming9Kok Khiang Peh10Bioxis Sdn. Bhd. PMT 1241, Jalan Perindustrian Bukit Minyak 8, Taman Perindustrian Bukit Minyak, Simpang Ampat 14100, MalaysiaBioxis Sdn. Bhd. PMT 1241, Jalan Perindustrian Bukit Minyak 8, Taman Perindustrian Bukit Minyak, Simpang Ampat 14100, MalaysiaBioxis Sdn. Bhd. PMT 1241, Jalan Perindustrian Bukit Minyak 8, Taman Perindustrian Bukit Minyak, Simpang Ampat 14100, MalaysiaSchool of Chemical Sciences, Universiti Sains Malaysia, Minden 11800, MalaysiaSchool of Chemical Sciences, Universiti Sains Malaysia, Minden 11800, MalaysiaCentre for Clinical Trial, Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Hospital Ampang, Ampang 68000, MalaysiaCentre for Clinical Trial, Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Hospital Ampang, Ampang 68000, MalaysiaCentre for Clinical Trial, Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Hospital Ampang, Ampang 68000, MalaysiaCentre for Clinical Trial, Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Hospital Ampang, Ampang 68000, MalaysiaPAP Rashidah Sa’adatul Bolkiah Institute of Health Sciences, Universiti Brunei Darussalam, Gadong BE 1410, BruneiSchool of Pharmaceutical Sciences, Universiti Sains Malaysia, Minden 11800, MalaysiaEtoricoxib is a non-steroidal anti-inflammatory drug (NSAID) used to treat pain and inflammation. The objective of the current study was to develop a sensitive, fast and high-throughput HPLC-ESI-MS/MS method to measure etoricoxib levels in human plasma using a one-step methanol protein precipitation technique. A tandem mass spectrometer equipped with an electrospray ionization (ESI) source operated in a positive mode and multiple reaction monitoring (MRM) were used for data collection. The quantitative MRM transition ions were <i>m/z</i> 359.15 > 279.10 and <i>m/z</i> 363.10 > 282.10 for etoricoxib and IS. The linear range was from 10.00 to 4000.39 ng/mL and the validation parameters were within the acceptance limits of the European Medicine Agency (EMA) and Food and Drug Analysis (FDA) guidelines. The present method was sensitive (10.00 ng/mL with S/N > 40), simple, selective (K prime > 2), and fast (short run time of 2 min), with negligible matrix effect and consistent recovery, suitable for high throughput analysis. The method was used to quantitate etoricoxib plasma concentrations in a bioequivalence study of two 120 mg etoricoxib formulations. Incurred sample reanalysis results further supported that the method was robust and reproducible.https://www.mdpi.com/1420-3049/27/17/5706etoricoxibetoricoxib D4protein precipitationhigh-sample throughputhuman plasmabioequivalence study |
| spellingShingle | Gabriel Onn Kit Loh Emily Yii Ling Wong Yvonne Tze Fung Tan Siew Chyee Heng Mardiana Saaid Kit Yee Cheah Nurul Diyana Mohd Sali Nair Damenthi Sharon Shi Min Ng Long Chiau Ming Kok Khiang Peh Fast and Sensitive HPLC-ESI-MS/MS Method for Etoricoxib Quantification in Human Plasma and Application to Bioequivalence Study Molecules etoricoxib etoricoxib D4 protein precipitation high-sample throughput human plasma bioequivalence study |
| title | Fast and Sensitive HPLC-ESI-MS/MS Method for Etoricoxib Quantification in Human Plasma and Application to Bioequivalence Study |
| title_full | Fast and Sensitive HPLC-ESI-MS/MS Method for Etoricoxib Quantification in Human Plasma and Application to Bioequivalence Study |
| title_fullStr | Fast and Sensitive HPLC-ESI-MS/MS Method for Etoricoxib Quantification in Human Plasma and Application to Bioequivalence Study |
| title_full_unstemmed | Fast and Sensitive HPLC-ESI-MS/MS Method for Etoricoxib Quantification in Human Plasma and Application to Bioequivalence Study |
| title_short | Fast and Sensitive HPLC-ESI-MS/MS Method for Etoricoxib Quantification in Human Plasma and Application to Bioequivalence Study |
| title_sort | fast and sensitive hplc esi ms ms method for etoricoxib quantification in human plasma and application to bioequivalence study |
| topic | etoricoxib etoricoxib D4 protein precipitation high-sample throughput human plasma bioequivalence study |
| url | https://www.mdpi.com/1420-3049/27/17/5706 |
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