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Spectrofluorimetric Method for the Determination of Azelastine Hydrochloride in Bulk and Nasal Formulations
Abstract
A reproducible, sensitive, and cost-effective spectrofluorimetric method has been developed for the quantification of azelastine hydrochloride in its bulk and nasal formulations. The stability-indicating potential of the method was assessed by recovery studies in the forced degraded solutions of the drug. The method was validated in accordance with the ICH guidelines with respect to linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ), and robustness. Excellent linearity was noted in the concentration range 2.0-40.0 μg/ml with a correlation coefficient (R2) of 0.9961. The limits of detection and quantitation for the proposed method were found to be 0.1598 μg/ml and 0.4845 μg/ml respectively. Excellent recovery of the drug was obtained from the proposed method in the nasal spray formulation of the drug (96.5, 0.66% RSD). The stability-indicating potential of the method was assessed from recovery studies of the drug from various forced-degraded samples spiked with known drug concentrations. The studies indicated a high rate of degradation in alkaline, oxidative, and photolytic stress degraded solutions.
Supporting agencies: This work was supported by the University Grants Commission (UGC), New Delhi, India (Grant No. 36/N/296). We sincerely thank Cipla Ltd., Mumbai (India) for graciously providing pure samples of azelastine HCl.
About the Authors
S. Shekhar
University Institute of Pharmaceutical Sciences, UGC Center of Advanced Study, Panjab University
India
India
Chandigarh, 160014.
A. Bali
University Institute of Pharmaceutical Sciences, UGC Center of Advanced Study, Panjab University
India
India
Chandigarh, 160014.
References
1. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20114S006_Astelin%20Nasal%20Spray_Approv.pdf.
2. M. D. Scarupa, M. A. Kaliner, World Allergy Org. J., 2, 20-25 (2009).
3. J. A. Bernstein, Curr. Med. Res. Opin., 23, 2441-2452 (2007).
4. C. Lee, J. Corren, Expert Opin. Pharmacother., 8, No. 5, 701-709 (2007).
5. L. M. da Costa, H. Oliveira de Almeida Leite, N. M. Kassab, A. K. Singh, Int. J. Anal. Chem., 1-11 (2019).
6. S. Patel, T. Y. Pasha, Asian J. Pharm. Clin. Res., 11, 248-251 (2018).
7. M. E. M. Hassouna, M. M. Abdelrahman, M. A. Mohamed, J. Forensic Sci. Criminal Invest., 1, 555565-555575 (2017).
8. B. Thangabalan, P. V. Kumar, Int. J. Pharm. Sci. Rev. Res., 17, 62-64 (2012).
9. K. L. N. Rao, K. P. Reddy, K. S. Babu, K. S. Raju, K. V. Rao, J. V. Shaik, Int. J. Res. Pharm. Sci., 1, 473-480 (2010).
10. R. Dubey, S. Das, S. Roychowdhury, K. K. Pradhan, M. Ghosh, Pharmbit, 27, 9-11 (2013).
11. N. S. Abdelwahab, N. F. Farid, M. Elagawany, E. H. Abdelmomen, Biomed. Chromatogr., 32, e4346 (2018).
12. N. N. Salama, S. A. Abdel-Razeq, S. Abdel-Atty, N. El-Kosy, Br. J. Pharm. Res., 79-92 (2014).
13. M. R. Elghobashy, O. M. Badran, M. Y. Salem, K. M. Kelani, Anal. Bioanal. Electrochem, 8, 325-340 (2013).
14. M. E. Hassouna, M. M. Abdelrahman, M. A. Mohamed, World, 2, 48-56 (2017).
15. S. K. Savale, Asian J. Biomater. Res, 3, 1-5 (2017).
16. A. A. Gouda, R. El Sheikh, H. El Saied, Can. Chem. Trans., 3, 29-41 (2015).
17. J. Y. Kim, J. Y. Choi, C. Y. Yoon, S. Cho, W. S. Kim, J. A. Do, J. Kor. Soc. Appl. Biol, 58, 137-147 (2015).
18. J. Y. Kim, J. A. Do, J. Y. Choi, S. Cho, W. S. Kim, C. Y. Yoon, Biomed. Chromatogr., 29, 465-474 (2015).
19. J. T. Yang, K. K. Wong, N. Kucharczyk, R. D. Sofia, Drug Metab. Dispos., 20, 536-540 (1992).
20. J. Pivonka, F. H. Segelman, C. A. Hartman, W. E. Segl, N. Kucharczyk, R. D. Sofia, J. Chromatogr. B: Biomed. Sci. Appl., 420, 89-98 (1987).
21. Y. S. Park, S. H. Kim, Y. J. Kim, S. C. Yang, M. H. Lee, L. M. Shaw, J. S. Kang, Int. J. Biomed. Sci., 6, 120-127 (2013).
22. U. Heinemann, G. Blaschke, N. Knebel, J. Chromatogr. B, 793, 389-404 (2003).
23. R. N. El-Shaheny, K. Yamada, Anal. Sci., 30, 691-697 (2014).
24. S. A. Abdel-Razeq, N. N. Salama, S. Abdel-Atty, N. El-Kosy, Pharm. Anal. Acta, 3, 1-4 (2012).
25. S. A. Abdel-Razeq, M. M. Foaud, N. N. Salama, S. Abdel-Atty, N. El-Kosy, In: Sensing in Electroanalysis, Eds. K. Kalcher, R. Metelka, I. Svancara, K. Vytfas, 6, University Press Centre, Pardubice, Czech Republic, 289-305 (2011).
26. ICH, Validation of Analytical Procedures: Text and Methodology Q2 (R1), Int. Conf. Harmonization, Geneva, Switzerland, 11, 1-13 (2005).
27. ICH, Photostability Testing of New Active Substances and Medicinal Products Q1B, Int. Conf. Harmonization, Geneva, Switzerland, 1-11 (1996).
28. https://chemaxon.com/products/calculators-and-predictors#pka.
Review
For citations:
Shekhar S., Bali A. Spectrofluorimetric Method for the Determination of Azelastine Hydrochloride in Bulk and Nasal Formulations. Zhurnal Prikladnoii Spektroskopii. 2021;88(3):506(1)-506(7).
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