DEVELOPMENT AND VALIDATION OF A NEW ANALYTICAL UV-VISIBLE SPECTROPHOTOMETRIC METHOD FOR THE ESTIMATION OF ALECTINIB IN API FORM AND MARKETED PHARMACEUTICAL DOSAGE FORM
Keywords:
UV-Spectroscopy, Alectinib, Method Development, Validation, AccuracyAbstract
Objective: The aim of this study is to develop three simple, specific and accurate spectrophotometric method for the determination of Alectinib in bulk and marketed pharmaceutical dosage form. Methods: In this method, the absorption spectrum of Alectinib is getting by 10μg/ml. In the developed method, the UV spectra were measured at 290 nm. Results: The proposed method was accurate, precise and selective for the determination of Alectinib in in pure form and in marketed pharmaceutical dosage form. Beer’s law was obeyed in the concentration range of 10–60μg/ml in this method. Conclusion: The developed method was used to determine the studied drug in bulk powder, laboratory prepared mixtures and pharmaceutical dosage form with good accuracy and precision. The method was validated according to ICH guidelines and the results obtained were statistically compared to those obtained from a reported method and were found to be in good agreement.
References
1. https://go.drugbank.com/drugs/DB11363
2. https://pubchem.ncbi.nlm.nih.gov/compound/Alectinib
3. https://en.wikipedia.org/wiki/Alectinib
4. Perkampus, H.H., 2013.UV-VIS Spectroscopy and its Applications. Springer Science & Business Media.
5. Gupta, Kumar and Sharma, Pragathi Prakashan Meerat-(1983)-Elements of Spectroscopy, 6th edition
6. Brown, J.Q., Vishwanath, K., Palmer, G.M. and Ramanujam, N., 2009. Advances in quantitative UV–visible spectroscopy for clinical and pre-clinical application in cancer.
7. Giusti, M.M. and Wrolstad, R.E., 2001. Characterization and measurement of Anthocyanins by UV‐visible spectroscopy.
8. Platt, U. and Stutz, J., 2008. Differential absorption spectroscopy. In Differential Optical Absorption Spectroscopy (pp. 135-174). Springer, Berlin, Heidelberg.
9. BV, D.C. and HYDRAULICS, D., 1962. Absorption spectroscopy.
10. Ajoy Ghatak, Tata Mc Grow Hill, (2009)-Textbook of Optics.
11. White, Tata Mc Graw Hill NY 1983-Atomic spectra.
12. C. Scott, S. Chand Co, (1998)-Introduction to optics and optical imaging
13. C. L. Arora, S. Chand publishing company, 2001-Atomic and molecular physics, 3rd edition.
14. Straughen and Walker, Vol I John Wiley & Sons 1976-Spectroscopy.
15. Beiser, Tata Mc Graw Hill 2003- Concepts of Modern Physics,.
16. H. S. Mani and G. K. Mehta, Affiliated East and West (1988)-Introduction to Modern Physics.
17. R. S. Sirohi, Orient Longman, (1993)-Wave optics and applications.
18. H. S. Mani and G. K. Mehta, Affiliated East and West (1988)-Introduction to Modern Physics.
19. Lambert, Joseph B.; et al. (1998), Organic Structural Spectroscopy, Prentice Hall, pp. 309–317, ISBN 0-13-258690-8.
20. Structure and the Optical Rotatory Dispersion of Saturated Ketones William Moffitt, R. B. Woodward, A. Moscowitz, W. Klyne, Carl Djerassi J. Am. Chem. Soc., 1961, 83 (19), pp 4013–4018.
21. The octant rule: Its place in organic stereochemistry William S. Murphy J. Chem. Educ., 1975, 52 (12), p 774 doi: 10.1021/ed052p774 Publication Date: December 1975
22. A Simple Computer-Aided Three-Dimensional Molecular Modeling for the Octant Rule Yinan Kang , Fu-An Kang J. Chem. Educ., 2011, 88 (4), p 420.
23. Skoog, Douglas A.; Holler, F. James; Crouch, Stanley R. (2007). Principles of Instrumental Analysis (6th Ed.), Belmont, CA: Thomson Brooks/Cole. pp. 169–173.
24. R. S. Drago (1992), Physical Methods for Chemists, 2nd Edition. W. B. Saunders.
25. Metha, Akul (13 December 2011), "Principle", PharmaXChange.info.
26. Metha, Akul (22 April 2012), "Derivation of Beer–Lambert Law", PharmaXChange.info.
27. Misra, Prabhakar; Dubinskii, Mark, Eds, (2002). Ultraviolet Spectroscopy and UV Lasers. New York: Marcel Dekker. ISBN 978-0-8247-0668-5.
28. Metha, Akul (14 May 2012), "Limitations and Deviations of Beer–Lambert Law"., PharmaXChange.info.
29. "Stray Light and Performance Verification".
30. "Wavelength Accuracy in UV/VIS Spectrophotometry".
31. Berberan-Santos, M. N. (September 1990), "Beer's law revisited", Journal of Chemical Education. 67 (9): 757. Bibcode: 1990JChEd.67.757B.
32. Wittung, Pernilla; Kajanus, Johan; Kubista, Mikael; Malmström, Bo G. (19 September 1994). "Absorption flattening in the optical spectra of liposome-entrapped substances". FEBS Letters. 352 (1): 37–40.
33. Ibañez, David; Garoz-Ruiz, Jesus; Heras, Aranzazu; Colina, Alvaro (2016-08-16), "Simultaneous UV–Visible Absorption and Raman Spectroelectrochemistry", Analytical Chemistry. 88 (16): 8210–8217.
34. ICH Q2B: Text on Validation of Analytical Procedures Methodology Step 4, Consensus Guidelines, ICH Harmonized Tripartite Guidelines, 1996.
35. Prashanthi Y, Tentu Nageswara Rao, Yellapu Srinivas, Method Development and Validation of Alectinib Drug by RP-HPLC in Bulk and Pharmaceutical Dosage Form. Asian J. Pharm. Ana. 2018; 8(4): 186-190. Doi: 10.5958/2231-5675.2018.00034.0.
36. M. Maithani1, D.K. Dwivedi2, V. Gupta3, P. Bansal3*, Analytical Method Development and Validation of Alectinib by RPHPLC Technique, International Journal of Pharmacy and Pharmaceutical Research, October 2023; Vol. 28 (3): 406-415.
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