Original scientific paper

https://doi.org/10.2478/v10007-011-0035-1

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

MOHAMMED A. ABONASSIF ; Pharmaceutical Chemistry Department, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh11451, Saudi Arabia
MOHAMMED M. HEFNAWY ; Pharmaceutical Chemistry Department, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh11451, Saudi Arabia
MOHAMED G. KASSEM ; Pharmaceutical Chemistry Department, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh11451, Saudi Arabia
GAMAL A. E. MOSTAFA ; Pharmaceutical Chemistry Department, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh11451, Saudi Arabia

Abstract

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 successfully used as an internal standard. Good chromatographic separation was achieved by using 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 min1. The analyte and internal standard were extracted from human plasma via liquid-liquid extraction. The proposed method was validated for 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 the quality control of donepezil hydrochloride in bulk drug as well as in human plasma.

Keywords

donepezil hydrochloride; RP-HPLC; dosage form; plasma

Hrčak ID:

71381

URI

https://hrcak.srce.hr/71381

Publication date:

31.12.2011.

Article data in other languages: croatian

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