- P-ISSN 1225-0163
- E-ISSN 2288-8985
Herein, we present a simple, precise, accurate, and ultra-sensitive spectrofluorimetric method for estimation of clozapine (CLZ) in tablets and human plasma was developed and then validated. A highly fluorescent brown-yellowish fluorophore was formed (λex=469 nm, λemi=540 nm) as a nucleophilic substitution reaction occurred between CLZ and 4-chloro-7-nitro-2,1,3-benzoxadiazole (NBD-Cl) in alkaline mcllavine buffer (pH 9.0). Optimum values of experimental parameters were carefully determined and optimized. The calibration curve was rectilinear over the concentration range of 80-900 ng mL−1 with a linear correlation coefficient (r =0.9984). The LOD and LOQ were determined to be 14 ng mL−1 and 42 ng mL−1, respectively. The proposed approach has been used successfully to quantification of Clozapine in its commercial formulations and human plasma.
1. M. W. Jann, Pharmacother. J. Hum. Pharmacol. Drug Ther., 11(3), 179-195 (1991).
2. M. G. Choc, F. Hsuan, G. Honigfeld, W. T. Robinson, L. Ereshefsky, M. L. Crismon, S. R. Saklad, J. Hirschowitz and R. Wagner, Pharm. Res., 7(4), 347-351 (1990).
3. M. A. Raggi, V. Pucci, F. Bugamelli and V. Volterra, J. AOAC Int., 84(2), 361-367 (2001).
4. A. Essali, N. A. H. Haasan, C. Li and J. Rathbone, Cochrane Database Syst. Rev., 2009(1), 1-174 (2009).
5. D. Siskind, L. McCartney, R. Goldschlager and S. Kisely, Br. J. Psychiatry, 209(5), 385-392 (2016).
6. P. B. Mitchell, in ‘Therapeutic drug monitoring of antidepressant and antipsychotic drugs’, Vol. 7, p257-275, Elsevier, 2020.
7. J. M. J. Alvir, J. A. Lieberman, A. Z. Safferman, J. L. Schwimmer and J. A. Schaaf, NEJM, 329(3), 162-167(1993).
8. F. Islam, D. Hain, D. Lewis, R. Law, L. Brown, J.-A. Tanner and D. J. Mueller, Biol. Psychiatry, 89(9), S341(2021).
9. N. Tunsirimas, P. Pariwatcharakul, S. Choovanichvong and W. Ratta-Apha, Asian J. Psychiatr., 41, 13-16(2019).
10. S. Rajagopal, in ‘Clozapine, agranulocytosis, and benign ethnic neutropenia’, The Fellowship of Postgraduate Medicine, 2005.
11. M. Hasegawa, P. A. Cola and H. Y. Meltzer, Neuropsychopharmacology, 11(1), 45-47 (1994).
12. M. Wiciński and M. M. Węclewicz, Curr. Opin. Hematol., 25(1), 22-28 (2018).
13. S. L. Gerson and H. Meltzer, Drug Safety, 7(1), 17-25(1992).
14. W. Ng, R. Kennar and J. Uetrecht, Chem. Res. Toxicol., 27(7), 1104-1108 (2014).
15. B. A. Sproule, C. A. Naranjo, K. E. Bremner and P. C. Hassan, Clin. Pharmacokinet., 33(6), 454-471 (1997).
16. U. A. Patil and B. Ghosh, Int. J. Pharm. Tech. Res., 1, 733-736 (2009).
17. https://go.drugbank.com/drugs/DB00363.
18. H. Ben-Yoav, S. E. Chocron, T. E. Winkler, E. Kim, D. L. Kelly, G. F. Payne and R. Ghodssi, Electrochim. Acta., 163, 260-270 (2015).
19. K. Farhadi and A. Karimpour, Anal. Sci., 23(4), 479-483 (2007).
20. U. Bondesson and L. H. Lindström, Psychopharmacology, 95(4), 472-475 (1988).
21. M. Rosland, P. Szeto, R. Procyshyn, A. M. Barr and K. M. Wasan, Drug Dev. Ind. Pharm., 33(10), 1158-1166(2007).
22. M. Raggi, F. Bugamelli, R. Mandrioli, D. De Ronchi and V. Volterra, Chromatographia, 49(1-2), 75-80 (1999).
23. Y. Liu, L. D. van Troostwijk and H. J. Guchelaar, Biomed. Chromatogr., 15(4), 280-286 (2001).
24. C. Wongsinsup, W. Taesotikul, S. Kaewvichit, S. Sangsrijan and S. Sangsrija, CMU. J. Nat. Sci., 9, 29-37 (2010).
25. E. Schulz, C. Fleischhaker and H. Remschmidt, Pharmacopsychiatry, 28(01), 20-25 (1995).
26. K. Manjunatha and V. Venkateshwarlu, Indian J. Pharm. Sci., 67(4), 448 (2005).
27. H. Weigmann, J. Bierbrauer, S. Härtter and C. Hiemke, Ther. Drug Monit., 19(4), 480-488 (1997).
28. E. Dural, G. MERGEN and T. SÖYLEMEZOĞLU, Turkish J. Pharm. Sci., 12(2), 177-186 (2015).
29. S. Mennickent, A. Sobarzo, M. Vega, C. G. Godoy and M. de Diego, J. Sep. Sci., 30(13), 2167-2172 (2007).
30. A. Avenoso, G. Facciolà, G. M. Campo, A. Fazio and E. Spina, J. Chromatogr. B Biomed. Appl., 714(2), 299-308 (1998).
31. A. M. Eldidamony, S. M. Hafeez and M. M. A. Hafez, Int. J. Pharm., 7(1), 178-184 (2015).
32. M. R. Fathi and D. Almasifar, IEEE Sens. J., 17(18), 6069-6076 (2017).
33. E. Reyhan, S. YILMAZ, S. YAĞMUR and Ö. T. YAYINTAŞ, J. Sci. Perspect., 1(2), 19-30 (2017).
34. K. A. Attia, A. El-Olemy, S. Ramzy, A. H. Abdelazim, M. A. Hasan, M. K. Omar and M. Shahin, Spectrochim. Acta A Mol. Biomol. Spectrosc., 244, Article 118871(2021).
35. Guideline, I. Q2 (R1): validation of analytical procedure:text and methodology. ICH, London 2005.
36. A. Ayman, A. M. Zeid, M. Wahba and E.-S. Yasser, Spectrochim. Acta A Mol. Biomol. Spectrosc., 238, Article 118447 (2020).