Volume : 12, Issue : 08, August- 2025
Title:
DEVELOPMENT AND VALIDATION OF A NEW ANALYTICAL UV SPECTROSCOPIC METHOD FOR ANALYSIS OF DONEPEZIL IN BULK POWDER AND TABLET DOSAGE FORM
Authors :
Srilaxmiprasanna*, S.Sneha, N.Shirisha, M.Poojitha, Karthik
Abstract :
A new simple, accurate, rapid, precise, reproducible and cost effective spectrophotometric method for the quantitative estimation of Donepezil in bulk and pharmaceutical dosage form. The developed visible spectrophotometric method for the quantitative estimation of Donepezil is based on measurement of absorption at maximum wavelength 278 nm using methanol as a solvent. The stock solution of Donepezil was prepared, and subsequent suitable dilution was prepared in distilled water to obtained standard curve. The standard solution of Donepezil shows absorption maxima at 278 nm. The drug obeyed beer lambert’s law in the concentration range of 0-60 μg/ml with regression 0.999 at 278 nm. The overall % recovery was found to be 100.167% which reflects that the method was free from the interference of the impurities and other excipients used in the bulk and marketed dosage form. The low value of % RSD was indicative of accuracy and reproducibility of the method. The % RSD for precision was found to be 0.864%. The %RSD for inter-day and intra-day precision was found to be 0.807 and 0.881 respectively which is <2% hence proved that method is precise. The results of analysis have been validated as per International Conference on Harmonization (ICH) guidelines. The developed method can be adopted in routine analysis of Donepezil in bulk and tablet dosage form.
Keywords: Donepezil, UV-Spectrophotometry, Methanol, Accuracy, Precision.
Cite This Article:
Please cite this article in press Srilaxmiprasanna et al., Development And Validation Of A New Analytical Uv Spectroscopic Method For Analysis Of Donepezil In Bulk Powder And Tablet Dosage Form., Indo Am. J. P. Sci, 2025; 12(08).
Number of Downloads : 10
References:
1. https://www.drugbank.ca/drugs/DB00843
2. https://pubchem.ncbi.nlm.nih.gov/compound/Donepezil
3. https://en.wikipedia.org/wiki/Donepezil
4. Skoog, Douglas A.; Holler, F. James; Crouch, Stanley R. (2007). Principles of Instrumental Analysis (6th Ed.). Belmont, CA: Thomson Brooks/Cole. pp. 169–173. ISBN 9780495012016.
5. Metha, Akul (13 Dec 2011). “Principle”. PharmaXChange.info.
6. Metha, Akul (22 Apr 2012). “Derivation of Beer-Lambert Law”. PharmaXChange.info.
7. Misra, Prabhakar; Dubinskii, Mark, eds. (2002). Ultraviolet Spectroscopy and UV Lasers. New York: Marcel Dekker. ISBN 0-8247-0668-4.
8. Metha, Akul (14 May 2012). “Limitations and Deviations of Beer-Lambert Law”. PharmaXChange.info.
9. Ansell, S.; Tromp, R. H.; Neilson, G. W. (1995). “The solute and Aquaion structure in a concentrated aqueous solution of copper (II) chloride”. J. Phys.: Condens. Matter. 7 (8): 1513–1524. Doi:10.1088/0953-8984/7/8/002.
10. L. Sooväli; Room, E.-I.; A. Kutt; et al. (2006). “Uncertainty sources in UV-Vis spectrophotometric measurement”. Accreditation and Quality Assurance (A & QC). 11: Pages-: 246–255.
11. Guidelines of Forensic Fiber Examination, Scientific Working Group-Materials, 1999, http://www.swgmat.org/fiber.htm
12. Micro Spectrophotometry and Colour Measurement in Forensic Paint Analysis Standard Guide, Scientific Working Group-Materials, Year-1999.
13. “UV–Visible Spectroscopic thin film thickness measurement system for semiconductor industries”, M. Horie; N. Fujiwara; M. Kokubo; Kondo, N., Proceedings of Instrumentation and Measurement Technology Conference, Hamamatsu, Japan, Year-1994.
14. Sertova (June 2000), “Photochromism of mercury (II) dithizonate in a solution”. Journal of Photochemistry and Photobiology Analytical Chemistry, (JPAPAC) 134 (3): Pages-: 163–168.
15. Principle of Ultraviolet-Visible Spectroscopy
16. Misra, Prabhakar; Dubinskii, Mark, eds. (2002). Ultraviolet Spectroscopy and UV Lasers. New York: Marcel Dekker. ISBN 0-8247-0668-4.
17. Mehta, Deviations of Beer Lambert Law S. Ansell Tromp, R. H.; Neilson, G. W. “The solute and structure of Aquaion in a concentrated aqueous copper solution (II) chloride”. J. Phys. Condens. Matter-7 (8): 1513.
18. L. Sooväli, E.-I. Room, A. Kütt, I. Kaljurand, I. Leito. Uncertainty sources in UV-Vis spectrophotometric measurement. Accredation. Quality Assurance. 2006, 11, 246-255.
19. Skoog, et al. Principles of Instrumental Analysis. 6th edition. Thomson Brooks/Cole. 2007, 349-351.
20. Skoog, et al. Principles of Instrumental Analysis. 6th edition. Thomson Brooks/Cole. 2007, pages-351.
21. Sharmila Dusi *, Method Development and Validation of Donepezil Hydrochloride, International Journal of Chemical and Pharmaceutical Analysis, Volume-6, Issue-3, Pages: 1-7.
22. Tanuja*, CH. Srujani, Varanasi. S. N. Murthy, Development and Validation of Novel UV spectrophotometric Method for the Estimation of Donepezil in Bulk and Pharmaceutical Dosage Form, Indo American Journal of Pharmaceutical Sciences, IAJPS 2015, 2 (8), 1147-1153.
23. Navya Sri, R. Sampath Kumar, S. Vinuthna, Md. Imran, Santhosh Illendula*, Ch. V. Suresh and K. N. V. Rao, Analytical Method Development and Validation of Donepezil Hcl in Tablet Dosage Form By UV Spectroscopic Method, European Journal of Biomedical AND Pharmaceutical sciences, ejbps, 2024, Volume 11, Issue 5, 276-280.
24. Vignesh K, Kokilambigai K. S* and Manikandan K, Spectrophotometric Analysis of Donepezil by Multivariate Calibration Analysis, International Journal of Biology, Pharmacy and Allied Sciences, IJBPAS, December, 2023, 12(12): 5599-5611.
25. Saiyed Fiza*, Dabhi Vaishali*, Dr. Hina L. Bagada, Development and Validation of Donepezil Hydrochloride in Bulk and Pharmaceutical Dosage Form By UV Spectroscopic Method, Journal of Global Trends in Pharmaceutical Sciences, 2024; 14(4): 760 – 767.




