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ARTICLES

Development of a green stability-indicating HPLC–DAD method for the determination of donepezil hydrochloride in the presence of its related substance and degradation products

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References

  • Pappa, H.; Farrú, R.; Vilanova, P. O.; Palacios, M.; Pizzorno, M. T. A New HPLC Method to Determine Donepezil Hydrochloride in Tablets. J. Pharm. Biomed. Anal. 2002, 27, 177–182.
  • Apostolou, C.; Dotsikas, Y.; Kousoulos, C.; Loukas, Y. L. Quantitative Determination of Donepezil in Human Plasma by Liquid Chromatography/Tandem Mass Spectrometry Employing an Automated Liquid–Liquid Extraction Based on 96-Well Format Plates Application to a Bioequivalence Study. J. Chromatogr. B 2007, 848, 239–244.
  • Furukori, N. Y.; Furuya, R.; Takahata, T.; Tateishi, T. Determination of Donepezil, an Acetylcholinesterase Inhibitor, in Human Plasma by High-performance Liquid Chromatography with Ultraviolet Absorbance Detection. J. Chromatogr. B 2002, 768, 261–265.
  • Matsui, K.; Oda, Y.; Nakata, H.; Yoshimura, T. Simultaneous Determination of Donepezil (Aricept) Enantiomers in Human Plasma by Liquid Chromatography–Electrospray Tandem Mass Spectrometry. J. Chromatogr. B 1999, 729, 147–155.
  • Nakashima, K.; Itoh, K.; Kono, M.; Nakashima, M. N.; Wada, M. Determination of Donepezil Hydrochloride in Human and Rat Plasma, Blood and Brain Microdialysates by HPLC with a Short C30 Column. Pharm. Biomed. Anal. 2006, 41, 201–206.
  • Xie, Z.; Liao, Q.; Xu, X.; Yao, M.; Wan, J.; Liu, D. Rapid and Sensitive Determination of Donepezil in Human Plasma by Liquid Chromatography/Tandem Mass Spectrometry: Application to a Pharmacokinetic Study. Rapid Commun. Mass Spectrom. 2006, 20, 3193–3198.
  • Pilli, N. R.; Inamadugu, J. K.; Kondreddy, N.; Karra, V. K.; Damaramadugu, R.; Rao, J. V. L. N. S. A Rapid and Sensitive LC–MS/MS Method for Quantification of Donepezil and Its Active Metabolite, 6-o-Desmethyl Donepezil in Human Plasma and Its Pharmacokinetic Application. Biomed. Chromatogr. 2011, 25, 943–951.
  • Katakam, P.; Kalakuntla, R. R.; Adiki, S. K.; Chandu, B. R. Development and Validation of a Liquid Chromatography Mass Spectrometry Method for the Determination of Donepezil in Human Plasma. J. Pharm. Res. 2013, 7, 720–726.
  • Gotti, R.; Bertucci, C.; Andrisano, V.; Pomponio, R.; Cavrini, V. Study of Donepezil Binding to Serum Albumin by Capillary Electrophoresis and Circular Dichroism. Anal. Bioanal. Chem. 2003, 377, 875–879.
  • Barot, T. G.; Patel, P. K. RP-HPLC Method for the Estimation of Donepezil Hydrochloride Dosage Form. E-J. Chem. 2009, 6, 594–600.
  • Babu, S.; Raju, K. N. RP-HPLC Method Development and Validation of Donepezil Hydrochloride. Int. J. Pharm. Pharm. Sci. 2012, 4, 213–216.
  • Singh, B. K.; Srivastava, R. K.; Kumar, S. S.; Dutta, P. K. Stability-Indicative HPLC Determination of Donepezil Hydrochloride in Tablet Dosage Form. Pharm. Chem. J. 2012, 45, 766–770.
  • Kumar, T. S.; Solairaj, P.; Thangathirupathi, A. Analytical Method Development and Validation of Donepezil Hydrochloride Tablets by RP­HPLC. Int. J. Pharm. Pharm. Sci. 2011, 3, 62–65.
  • Gotti, R.; Cavrini, V.; Pomponio, R.; Andrisano, V. Analysis and Enantioresolution of Donepezil by Capillary Electrophoresis. J. Pharm. Biomed. Anal. 2001, 24, 863–870.
  • Shirwaikar, A.; Devi, S.; Rajagopal, P. L.; Kiron, S. S.; Sreejith, K. R. Development and Validation of Analytical Method for Determination of Donepezil Hydrochloride in Pure and Dosage Forms. Asian J. Pharm. Clin. Res. 2014, 7, 149–153.
  • Shirwaikar, A.; Devi, S.; Rajagopal, P. L.; Kiron, S. S.; Sreejith, K. R. Ion Pair Extraction Method for Determination of Donepezil Hydrochloride in Pure and Dosage Forms. IJRPBS 2013, 4, 1386–1393.
  • The United States Pharmacopeia 38th Edn.; The National Formulary, 33th Edn.; The Official Compendia of Standards. United States Pharmacopoeial Convention, Inc.: Rockville, MD, 2015 (Asian Edition).
  • Kidwai, M.; Mohan, R. Green Chemistry: An Innovative Technology. Found. Chem. 2005, 7, 279–287.
  • Warner, J. C.; Cannon, A. S.; Dye, K. M. Green Chemistry. Environ. Impact Assess. Rev. 2004, 24, 775–799.
  • Gałuszka, A.; Migaszewski, Z.; Namieśnik, J. The 12 Principles of Green Analytical Chemistry and the SIGNIFICANCE Mnemonic of Green Analytical Practices. Trends Anal. Chem. 2013, 50, 78–84.
  • ICH. Q1B Stability Testing: Photo-Stability Testing of New Drug Substances and Products, International Conference on Harmonisation: Geneva, November, 1996.
  • Welch, C. J.; Brkovic, T.; Schafer, W.; Gong, X. Performance to Burn? Re-Evaluating the Choice of Acetonitrile as the Platform Solvent for Analytical HPLC. Green Chem. 2009, 11, 1232–1238.
  • Aleksandar, R. M.; Milka, B. J.; Aleksandar, D. P.; Slobodan, D. P.; SaŠa, Z. D.; Milka, L. A.; Dušan, Ž. M. Liquid Chromatography and Liquid Chromatography–Mass Spectrometry Analysis of Donepezil Degradation Products. Chem. Ind. Chem. Eng. Q. 2015, 21, 447–455.
  • Sreelatha, P.; Reddy, D. V.; Palavai, S. R.; Devi, R. Impurity Profiling for Donepzil Hydrochloride Tablet Formulations and Characterisation of Potential Degradant. Am. J. PharmTech Res. 2016, 6, 213–229.
  • ICH. Q2A (R1) Validation of Analytical Procedures: Text and Methodology, International Conference on Harmonisation: Geneva, November, 2005.
  • Armitage, P.; Berry, G. Statistical Methods in Medical Research, 3rd ed.; Blackwell Scientific Publications: Oxford, England, 1994.
  • Miller, J. N.; Miller, J. C. Statistics and Chemometrics for Analytical Chemistry, 5th ed.; Prentice Hall: Harlow, England, 2005.
  • Tobiszewski, M.; Marc, M.; Galuszka, A.; Namiesnik, J. Green Chemistry Metrics with Special Reference to Green Analytical Chemistry. Molecules 2015, 20, 10928–10946.
  • David, J. C. Solvent Considerations in Green Chemistry. ACS Green Chemistry Institute: Washington, DC, USA, 2013. http://www.industrialgreenchem.com/pdf-docs/presentations/igcw%202013/green%20solvents/David%20J.%20C.%20Constable.pdf (accessed on 6 November 2017).
  • Galuszka, A.; Konieczka, P.; Migaszewski, Z. M.; Namieśnik, J. Analytical Eco-Scale for Assessing the Greenness of Analytical Procedures. Trends Anal. Chem. 2012, 37, 61–72.
  • Gaber, Y.; Törnvall, Y.; Kumar, M. A.; Amin, M. A.; Kaul, R. H. HPLC-EAT (Environmental Assessment Tool): A Tool for Profiling Safety, Health and Environmental Impacts of Liquid Chromatography Methods. Green Chem. 2011, 13, 2021–2025.

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