Amlodipine bioequivalence study: quantification by liquid chromatography coupled to tandem mass spectrometry
| العنوان: | Amlodipine bioequivalence study: quantification by liquid chromatography coupled to tandem mass spectrometry |
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| المؤلفون: | Celso H. Oliveira, M. Carvalho, Gustavo D. Mendes, Maria Elisabete Amaral de Moraes, G. De Nucci, M. Sucupira |
| المصدر: | Biopharmaceutics & Drug Disposition. 22:383-390 |
| بيانات النشر: | Wiley, 2001. |
| سنة النشر: | 2001 |
| مصطلحات موضوعية: | Adult, Male, Adolescent, Chemistry, Pharmaceutical, Cmax, Pharmaceutical Science, Bioequivalence, High-performance liquid chromatography, Mass Spectrometry, Dosage form, Pharmacokinetics, Confidence Intervals, medicine, Humans, Pharmacology (medical), Amlodipine, Antihypertensive Agents, Chromatography, High Pressure Liquid, Pharmacology, Cross-Over Studies, Chromatography, Chemistry, Selected reaction monitoring, General Medicine, Crossover study, Therapeutic Equivalency, Linear Models, Female, Tablets, medicine.drug |
| الوصف: | Objective—To assess the bioequivalence of two amlodipine tablet formulations (Amlodipine® 5 mg tablet from Merck S.A. Industrias Quimicas, Brazil as test formulation and Norvasc® 5 mg tablet from Laboratorios Pfizer Ltd., Brazil as reference formulation) in 24 healthy volunteers of both sexes. Methods—The study was conducted using an open, randomized two-period crossover design with a 4-week washout interval. Plasma samples were obtained over a 144 h period. Plasma amlodipine concentrations were analyzed by combined liquid chromatography coupled to tandem mass spectrometry (LC-MS-MS) with positive ion electrospray ionization using multiple reaction monitoring (MRM). From the amlodipine plasma concentration vs time curves, the following pharmacokinetic parameters were obtained: AUClast, AUC0–inf and Cmax. The statistical interval proposed was 80–125% according to the US Food and Drug Administration Agency. Results—The limit of quantification was 0.1 ng/ml for plasma amlodipine analysis. The geometric mean and the 90% confidence interval (CI) test/reference ratios were 101.2 (92.9–110.2%) for AUClast, 99.6 (91.5–108.4%) for AUC0–inf and 98.5 (89.0–109.1%) for Cmax. Conclusion—Since the 90% CI for AUClast, AUC0–inf and Cmax ratios were within in the 80–125% interval proposed by the US FDA, it was concluded that Amlodipine® 5 mg tablet (test formulation) was bioequivalent to Norvasc® 5 mg tablet, in terms of both rate and extent of absorption. Copyright © 2001 John Wiley & Sons, Ltd. |
| تدمد: | 1099-081X 0142-2782 |
| DOI: | 10.1002/bdd.282 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4aaadf9814be5b96fd0b9b88bf1b7f03 https://doi.org/10.1002/bdd.282 |
| Rights: | CLOSED |
| رقم الانضمام: | edsair.doi.dedup.....4aaadf9814be5b96fd0b9b88bf1b7f03 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 1099081X 01422782 |
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| DOI: | 10.1002/bdd.282 |