New gradient high-performance liquid chromatography method for determination of donepezil hydrochloride assay and impurities content in oral pharmaceutical formulation

Journal of Chromatography. a
Stella KafkalaMaria Katsiabani

Abstract

A new gradient HPLC method has been developed and validated for the determination of both assay and related substances of donepezil hydrochloride in oral pharmaceutical formulation. Different kinds of columns and gradient elution programs were tested in order to achieve satisfactory separation between the active substance, four impurities and an interfering excipient used in the formulation. The best results were obtained using an Uptisphere ODB C-18 column 250 mm x 4.6 mm, 5 microm, UV detection at 270 nm and a gradient elution of phosphate buffer (0.005 M, pH 3.67) and methanol as the mobile phase. The method was validated with respect to linearity, precision, accuracy, specificity and robustness. It was also found to be stability indicating, and therefore suitable for the routine analysis of donepezil hydrochloride and related substances in the pharmaceutical formulation.

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Citations

Aug 24, 2013·Journal of Pharmaceutical and Biomedical Analysis·Deepti Jain, Pawan Kumar Basniwal
Dec 29, 2011·Acta Pharmaceutica : a Quarterly Journal of Croatian Pharmaceutical Society and Slovenian Pharmaceutical Society, Dealing with All Branches of Pharmacy and Allied Sciences·Mohammed A AbonassifGamal A E Mostafa
Mar 23, 2011·Drug Development and Industrial Pharmacy·Kyung Hee Kim, Hye Sun Gwak
Dec 15, 2010·Biomedical Chromatography : BMC·Lygia Azevedo MarquesWilfried Ma Niessen
May 8, 2009·Analytical Chemistry·R K Gilpin, C S Gilpin

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