Asimple, selective, precise and stability-indicative high-performance liquid chromatography (HPLC) method of analysis of donepezil hydrochloride in tablet dosage form has been developed and validated. The drug undergoes degradation under acidic, basic, peroxide, photochemical and thermal conditions. The method has been statistically validated for linearity, accuracy, precision, limit of detection, limit of quantitation, solution stability, and selectivity according to ICH recommendations. Due to its simplicity and accuracy, the method can be used for routine drug quality control.
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Acknowledgments
The authors are greatly thankful to Jubilant Organosys Pvt. Ltd. (Noida, India) for providing reference substance of donepezil hydrochloride as a gift. One of the authors (B. K. S.) is also thankful to Council of Scientific and Industrial Research (New Delhi, India) for providing financial support in the form of major research project.
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Singh, B.K., Srivastava, R.K., Kumar, S.S. et al. Stability-indicative HPLC determination of donepezil hydrochloride in tablet dosage form. Pharm Chem J 45, 766–770 (2012). https://doi.org/10.1007/s11094-012-0721-4
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DOI: https://doi.org/10.1007/s11094-012-0721-4