Simultaneous determination of novel ketolide antibiotic nafithromycin and its major metabolite in human plasma using liquid chromatography tandem mass spectrometry.
| Autor: | Patil KR; Wockhardt Research Centre, Analytical, Drug Discovery, D-4, MIDC, Aurangabad, 431006, India., Yeole RD; Wockhardt Research Centre, Analytical, Drug Discovery, D-4, MIDC, Aurangabad, 431006, India., Zwart M; PRA Health Sciences - Early Development Services, Bioanalytical Laboratory, Amerikaweg 18, 9407 TK Assen, The Netherlands., Pruim P; PRA Health Sciences - Early Development Services, Bioanalytical Laboratory, Amerikaweg 18, 9407 TK Assen, The Netherlands. |
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| Jazyk: | angličtina |
| Zdroj: | Bioanalysis [Bioanalysis] 2019 Oct; Vol. 11 (19), pp. 1767-1776. Date of Electronic Publication: 2019 Oct 22. |
| DOI: | 10.4155/bio-2019-0153 |
| Abstrakt: | Aim: A sensitive method to quantify nafithromycin and its N-desmethyl metabolite in human plasma was necessary for Phase I pharmacokinetic studies. Methodology: A precise and accurate LC-MS/MS bioanalytical method has been developed and validated for the simultaneous quantification of nafithromycin (NFT, WCK 4873) and N-desmethyl metabolite (M1, WCK 4978) in human plasma. Clarithromycin was used as an internal standard. Protein precipitation technique was used as sample preparation approach. The calibration curve was linear (r ≥ 0.99) over the concentration range of 10-5000 ng/ml for NFT and M1. Method was validated as per US FDA guideline. Conclusion: The proposed method was successfully applied for determination of plasma levels of the NFT and M1 during Phase I clinical studies. |
| Databáze: | MEDLINE |
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