Development of HPLC method coupled with fluorescence detection for simultaneous determination of donepezil HCl and trazodone HCl in spiked human plasma and tablets dosage forms - 28/06/19
Développement de la méthode de CLHP couplée à la détection de la fluorescence pour la détermination simultanée de chlorhydrate de donépézil et de chlorhydrate de trazodone dans le plasma humain dopé et les forme galénique comprimés
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Highlights |
• | A novel and sensitive RP-HPLC method with fluorescence detection for simultaneous bioanalytical determination of Donepezil hydrochloride (DON) and co-administered, Trazodone hydrochloride (TRA) in their pure forms, spiked human plasma and tablet dosage forms. |
• | Elution of both drugs was achieved with excellent resolution within 7min. A Fluorescence detector at 300nm for excitation and 400nm for emission was used. |
• | Linearity ranges of the assay were 25–1000 and 50–5000 ng/mL and the limits of detection (LOD) and quantitation (LOQ) were 8.52, 15.47 and 25.81, 46.89 ng/mL for Donepezil hydrochloride and Trazodone hydrochloride, respectively. |
• | The high sensitivity of the proposed method enabled the successful determination of the cited drugs in spiked human plasma with mean percentage of recoveries of 91.58±3.34 and 100.30±5.11 for Donepezil hydrochloride and Trazodone hydrochloride, respectively. |
Summary |
Objectives |
Elderly people with dementia are commonly suffered from sleep disorders. So, the use of Donepezil hydrochloride as anti-Alzheimer drug and Trazodone hydrochloride as antidepressants with hypnotic action is very important in these cases. This study reports about novel and sensitive RP-HPLC method with fluorescence detection for simultaneous bioanalytical determination of Donepezil hydrochloride (DON) and co-administered, Trazodone hydrochloride (TRA) in their pure forms, spiked human plasma and tablets.
Materials and methods |
Elution of both drugs was achieved with excellent resolution using a RP-C18 Hypersil Gold column and an isocratic mobile phase consisting of phosphate buffer (50mm, pH 4.6): methanol: acetonitrile (60:35:5) with a flow rate of 1.5mL/min and 20μL as injection volume. A Fluorescence detector at 300nm for excitation and 400nm for emission was used.
Results |
Retention times were 4.3 and 6.3min for Donepezil hydrochloride and Trazodone hydrochloride, respectively. Linearity ranges of the assay were 25–1000 and 50–5000ng/mL and the limits of detection (LOD) and quantitation (LOQ) were 8.52, 15.47 and 25.81, 46.89ng/mL for Donepezil hydrochloride and Trazodone hydrochloride, respectively.
Conclusion |
The high sensitivity of the proposed method enabled the successful determination of the cited drugs in spiked human plasma with mean percentage of recoveries of 91.58±3.34 and 100.30±5.11 for Donepezil hydrochloride and Trazodone hydrochloride, respectively.
Il testo completo di questo articolo è disponibile in PDF.Résumé |
Objectifs |
Les personnes âgées atteintes de démence peuvent souffrir de troubles du sommeil. Ainsi, l’utilisation du chlorhydrate de donépézil en tant que médicament anti-Alzheimer et du chlorhydrate de trazodone en tant qu’antidépresseur peuvent avoir leur importance dans ces cas. Cette étude présente une nouvelle méthode CLHP sensible avec détection par fluorescence pour la détermination bioanalytique simultanée du chlorhydrate de donépézil (DON) et du chlorhydrate de trazodone (TRA) en association dans la matière première, le plasma humain enrichi et des comprimés.
Matériels et méthodes |
L’élution des deux médicaments a été réalisée avec une excellente résolution en utilisant une colonne Hypersil Gold RP-C18 et une phase mobile isocratique consistant en un tampon phosphate (50mm, pH 4,6) : méthanol : acétonitrile (60 : 35 : 5) avec un débit de 1,5mL/min et 20μL en volume d’injection. Un détecteur de fluorescence à 300nm pour l’excitation et à 400nm pour l’émission a été utilisé.
Résultats |
Les temps de rétention étaient respectivement de 4,3 et 6,3min pour le chlorhydrate de donépézil et le chlorhydrate de trazodone. Les plages de linéarité du test étaient comprises entre 25–1000 et 50–5000ng/mL et les limites de détection (LOD) et de quantification (LOQ) étaient de 8,52, 15,47 et 25,81, 46,89ng/mL pour le chlorhydrate de donépézil et le chlorhydrate de trazodone, respectivement.
Conclusion |
La haute sensibilité de la méthode proposée a permis de déterminer avec succès les médicaments cités dans le plasma humain enrichi avec des pourcentages moyens de récupération de 91,58±3,34 et de 100,30±5,11 pour le chlorhydrate de donépézil et le chlorhydrate de trazodone, respectivement.
Il testo completo di questo articolo è disponibile in PDF.Keywords : HPLC method, Fluorescence detection, Donepezil hydrochloride, Trazodone hydrochloride, Plasma, Tablets
Mots clés : Méthode CLHP, Détection par fluorescence, Chlorhydrate de donépézil, Chlorhydrate de Trazodone, Plasma, Comprimés
Mappa
Vol 77 - N° 4
P. 286-294 - luglio 2019 Ritorno al numero
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