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Paper Details

Validation of a new simple Reverse Phase-HPLC method for determination of Donepezil hydrochloride

Sukhbir Lal Khokra, Hitesh Dhamija, Abhishek Chandel, Deepika Gupta Sunil Dutt and Bharat Parashar

Journal Title:Journal of Chemical, Biological and physical sciences
Abstract


A rapid, simple, specific, sensitive, precise, accurate and reliable reverse phase high performance liquid chromatographic method has been developed for the estimation of Donepezil hydrochloride tablets. Donepezil is a reversible acetyl cholinesterase inhibitor which is used in the treatment of Alzheimers disease. A mixture of buffer (6.8 g of potassium dihydrogen orthophosphate in 100 mL of water then 5 mL Triethylamine, pH adjusted to 2.2 0.1), methanol (60:40 V/V) as mobile phase was delivered at a flow rate 1.2 mL/min and wavelength of detection at 286 nm using reverse phase column Hypersil BDS C18, 100 mm 4.6 mm, 5?m. The retention time was found to be 11.45. The method was statistically validated for linearity, accuracy, precision selectivity, specificity, solution stability, filter compatibility, filter saturation, robustness and system suitability as per ICH guidelines. The method is advantageous as the standard and sample preparation requires less time and no tedious extraction procedure was involved in the analysis of formulation. The method can be effectively applied for routine analysis in research institutions, quality control department in industries, approved testing laboratories, bio-pharmaceutics & bio-equivalence studies and in clinical pharmacokinetic studies.

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