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Acta Pharmaceutica

The Journal of Croatian Pharmaceutical Society

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Volume 61, Issue 4 (Dec 2011)

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Determination of donepezil hydrochloride in human plasma and pharmaceutical formulations by HPLC with fluorescence detection

Mohammed Abonassif
  • Pharmaceutical Chemistry Department College of Pharmacy, King Saud University, P.O. Box 2457 Riyadh 11451, Saudi Arabia
/ Mohammed Hefnawy
  • Pharmaceutical Chemistry Department College of Pharmacy, King Saud University, P.O. Box 2457 Riyadh 11451, Saudi Arabia
/ Mohamed Kassem
  • Pharmaceutical Chemistry Department College of Pharmacy, King Saud University, P.O. Box 2457 Riyadh 11451, Saudi Arabia
/ Gamal Mostafa
  • Pharmaceutical Chemistry Department College of Pharmacy, King Saud University, P.O. Box 2457 Riyadh 11451, Saudi Arabia
Published Online: 2011-12-25 | DOI: https://doi.org/10.2478/V10007-011-0035-1

Determination of donepezil hydrochloride in human plasma and pharmaceutical formulations by HPLC with fluorescence detection

A sensitive, isocratic reversed-phase high performance liquid chromatographic method involving fluorescence detection was developed for the determination of donepezil hydrochloride in tablets and in human plasma. Pindolol was used as an internal standard. Good chromatographic separation was achieved by using an analytical column C18. The system operated at room temperature using a mobile phase consisting of methanol, phosphate buffer (0.02 mol L-1) and triethyl amine (pH 3.5) (55: 45: 0.5, V/V/V) at a flow rate 0.9 mL-1 min. The analyte and internal standard were extracted from human plasma via liquid-liquid extraction. The proposed method was validated for sensitivity, selectivity, linearity, accuracy and precision. The calibration curve was linear over the range of 5-2000 ng mL-1 of donepezil with detection limit of 1.5 ng mL-1. Intra- and inter-day relative standard deviations were less than 2.5 %. The method was found to be suitable for quality control of donepezil hydrochloride in bulk drug as well as in human plasma.

Određivanje donepezil hidroklorida u humanoj plazmi i ljekovitim oblicima pomoću HPLC s detekcijom fluorescencije

Ovaj rad opisuje HPLC metodu određivanja donepezil hidroklorida (DP) u tabletama i u ljudskoj plazmi u nano području. Postavljena je osjetljiva metoda izokratične HPLC s fluorescencijskom detekcijom. Kao unutarnji standard upotrebljen je pindolol. Dobro kromatografsko odjeljivanje postignuto je primjenom analitičke kolone C18. Radna temperatura bila je sobna, a kao mobilna faza upotrebljena je smjesa metanola, fosfatnog pufera (0,02 mol L-1) i trietilamina (pH 3,5) (55: 45: 0.5, V/V/V). Analit i unutarnji standard su ekstrahirani iz ljudske plazme ekstrakcijom tekuće-tekuće. Predložena metoda je validirana s obzirom na selektivnost, područje linearnosti, ispravnost i preciznost. Kalibracijska funkcija bila je linearna u području od 5-2000 ng mL-1 donepezila, a granica detekcije iznosila je 2 ng mL-1. Relativna standardna devijacija za repetabilnost i intermedijarnu preciznost bila je manja od 2,5 %. Metoda je primjenljliva u kontroli kvalitete ljekovitih formulacija s DP-om i u praćenju DP-a u ljudskoj plazmi.

Keywords: donepezil hydrochloride; RP-HPLC; fluorescence detection; dosage form; plasma

Keywords: donepezil; RP-HPLC; dozirani oblik; plazma

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About the article


Published Online: 2011-12-25

Published in Print: 2011-12-01



Citation Information: Acta Pharmaceutica, ISSN (Online) 1846-9558, ISSN (Print) 1330-0075, DOI: https://doi.org/10.2478/V10007-011-0035-1. Export Citation

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