Simultaneous quantitation of rosuvastatin and ezetimibe in human plasma by LC-MS/MS: Pharmacokinetic study of fixed-dose formulation and separate tablets.
Biomed Chromatogr
; 32(10): e4291, 2018 Oct.
Article
en En
| MEDLINE
| ID: mdl-29782035
ABSTRACT
A simple, high-throughput and highly sensitive liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) method has been developed for the simultaneous estimation of rosuvastatin and free ezetimibe. Liquid-liquid extraction was carried out using methyl-tert butyl ether after prior acidification from 300 µL human plasma. The recovery for both the analytes and their deuterated internal standards (ISs) ranged from 95.7 to 99.8%. Rosuvastatin and ezetimibe were separated on Symmetry C18 column using acetonitrile and ammonium formate buffer, pH 3.5 (3070, v/v) as the mobile phase. The analytes were well resolved with a resolution factor of 3.8. Detection and quantitation were performed under multiple reaction monitoring using ESI(+) for rosuvastatin (m/z 482.0 â 258.1) and ESI(-) for ezetimibe (m/z 407.9 â 271.1). A linear response function was established in the concentration ranges of 0.05-50.0 ng/mL and 0.01-10.0 ng/mL for rosuvastatin and ezetimibe, respectively, with correlation coefficient, r2 ≥ 0.9991. The IS-normalized matrix factors for the analytes ranged from 0.963 to 1.023. The developed method was successfully used to compare the pharmacokinetics of a fixed-dose combination tablet of rosuvastatin-ezetimibe and co-administered rosuvastatin and ezetimibe as separate tablets to 24 healthy subjects. The reliability of the assay was also assessed by reanalysis of 115 subject samples.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Cromatografía Liquida
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Espectrometría de Masas en Tándem
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Rosuvastatina Cálcica
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Ezetimiba
Tipo de estudio:
Clinical_trials
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Diagnostic_studies
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Prognostic_studies
Límite:
Adult
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Biomed Chromatogr
Año:
2018
Tipo del documento:
Article
País de afiliación:
India