Donepezil Hydrochloride Lab Report

Abstract: A simple, eco-friendly, stability-indicating HPLC method was developed for the determination of Donepezil Hydrochloride (DH) in tablet dosage form in presence of its pharmacopoeial related compound (Donepezil related compound A) and its different degradation products. The chromatographic conditions were optimized to achieve the highest performance parameters using Zorbax Eclipse Plus C18 rapid resolution column (4.6 X 100 mm, 3.5 µm), with a mobile phase composed of 72.5 % acetate buffer pH 5.5 and 27.5 % ethanol, flowing at 1 ml min-1. The Diode Array Detector (DAD) was set at 315 nm and the column oven was adjusted at 45 °C. The method was validated according to the ICH guidelines with respect to system suitability, specificity,
The mean relative standard deviation (R.S.D %) of the results of precision and accuracy of the drug were ≤2%. Forced degradation studies were performed on standard DH and test Demepezil® 5 mg tablets under various conditions and the method was found to be stability indicating. The purity of the DH peak was confirmed using the DAD. In the developed method two principles of green chromatography were adopted (reduce and replace) by reducing solvent consumption through the utilisation of a short column (10 cm) with a smaller particle size (3.5 µm) instead of a normal 25 cm with a 5 µm particle size and by replacing hazardous solvents of the official USP method as acetonitrile with ethanol. Furthermore, the greenness of the method was assessed using National Environmental Methods Index label, Eco scale methods and Environmental Assessment
Green Chemistry is the utilization of set of principles that reduces or eliminates the use of hazardous substances in the design, manufacture and application of chemical products (18, 19). Green chemistry concerns the role of analytical chemists in making laboratory practices friendlier to the environment, and it has gained a great deal of interest among chemists (20).
The aim of this paper is to develop a simple, green, stability-indicative chromatographic method for determination of DH in its tablets in presence of its specific pharmacopoeial related compound, Donepezil related compound A, ((E)-2-[(1-Benzylpiperidin-4-yl)methylene]-5,6-dimethoxyindan-1-one), (Figure 1b) with suitable resolution comparable to that stated by official USP monograph. In the same time, the assay was done in presence of DH different degradation products by applying two important principle of green chromatography; which are reducing solvent by using a short column (10 cm) with a smaller particle size (3.5 µm) instead of a normal 25 cm with a 5 µm particle size column and replacing solvent by replace Acetonitrile and perchloric acid by the greener one,