|Generate QR code
Open Access
Subscription Access
Validated Spectrofluorimetric Method for Estimation of Idelalisib in Bulk and in Formulation
Abstract
Idelalisib is a phosphatidylinositol 3-kinase delta inhibitor approved by the USFDA and EMA for the treatment of lympholytic lymphoma, B-cell non-Hodgkin lymphoma and lymphocytic lymphoma. The present report describes the validation of simple, rapid, sensitive, and cost-effective spectrofluorimetric methods based on the native fluorescence of the drug in an acidic medium. Fluorescence characteristics of the drug were found to significantly differ in absolute ethanol (λex = 330 and λem = 595 nm) and HCl (λex = 270 and λem = 350 nm) and both methods were validated as per ICH guidelines. The two methods were extremely sensitive, precise and accurate demonstrating excellent linearity in concentration ranges from 0.1–2.0 μg/mL (absolute ethanol) and 0.1–20 μg/mL (HCl). The LOD and LOQ values were found to be 0.015 and 0.045 µg/mL (ethanol) and 0.1615 and 0.4894 µg/mL (HCl). The proposed methods were used to quantify the drug in its marketed tablet formulation with good recoveries, suggesting their applicability to routine analysis of the drug in bulk as well as in formulation.
Supporting agencies: This work was supported by the University Grants Commission (UGC), New Delhi, India (Grant No. 36/N/296).
About the Authors
M. Mahesh
University Institute of Pharmaceutical Sciences, UGC Center of Advanced Study at Panjab University
India
India
Chandigarh
A. Bali
University Institute of Pharmaceutical Sciences, UGC Center of Advanced Study at Panjab University
India
India
Chandigarh
T. Gupta
University Institute of Pharmaceutical Sciences, UGC Center of Advanced Study at Panjab University
India
India
Chandigarh
References
1. A. Davies, Expert Rev. Hematol., 8, No. 5, 581–593 (2015).
2. L. A. Raedler, Am. Health Drug Benefits, 8, 157–162 (2015).
3. A. Markham, Drugs, 74, No. 14, 1701–1707 (2014).
4. https://www.accessdata.fda.gov/drugsatfda_docs /label/2014/20654.5lBl.pdf (accessed: June 09, 2023).
5. http://www.ema.europa.eu/ema/in-dex.jsp?curl¼human/medicines/003843/human_med_001803.jsp (accessed: June 09, 2023).
6. R. R. Furman, J. P. Sharman, S. E. Coutre, B. D. Cheson, J. M. Pagel, P. Hillmen, J. C. Barrientos, A. D. Zelenetz, T. J. Kipps, I. Flinn, P. Ghia, H. Eradat, T. Ervin, N. Lamanna, B. Coiffier, A. R. Pettitt, S. Ma, S. Stilgenbauer, P. Cramer, M. Aiello, D. M. Jhonson, L. L. Miller, D. Li, T. M. Jahn, R. D. Dansey, M. Hallek, S. M. O’Brien, N. Engl. J. Med., 370, No. 11, 997–1007 (2014).
7. V. Bommuluri, S. Vajjha, C. S. Rumalla, S. Kadari, R. Doddipalla, M. Kaliyaperumal, R. B. Korupolu, SN Appl. Sci., 1, 915 (2019).
8. A. Suneetha, D. Sharmila, Int. J. Pharm. Sci. Res., 7, No. 12, 4998(1–5) (2016).
9. H. H. Huynh, C. Roessle, H. Sauvageon, A. Ple, I. Madelaine, C. Thieblemont, S. Mourah, L. Goldwit, Ther. Drug Monit., 40, 237–244 (2018).
10. H. K. Tripathy, N. V. S. Manju, S. Dittakavi, A. Zakkula, R. Mullangi, Drug Res., 71, No. 1, 36–42 (2021).
11. C. Wang, F. Jia, Y. Zhang, Biomed. Chromatogr., 33, e4511 (2019).
12. S. Veeraraghavan, S. Thappali, S. Viswanadha, S. Vakkalanka, M. Rangaswamy, Sci. Pharm., 84, No. 2, 347–359 (2015), doi: 10.3797/scipharm.1510-08.
13. B. B. Gabani, S. Dittakavi, P. K. Kurakula, U. Todmal, M. Zainuddin, R. K. Trivedi, R. Mullangi, Anal. Chem., 11, No. 2, 140–152 (2021).
14. ICH, Validation of Analytical Procedures: Text and Methodology Q2 (R1), Int. Conf. Harmonization, Geneva, Switzerland, 11, 1–13 (2005).
15. ZYDELIG Product Information v4.0, https://www.tga.gov.au/sites/default/files/ausparidelalisib171019pi.pdf (accessed: February 21, 2022).
Review
For citations:
Mahesh M., Bali A., Gupta T. Validated Spectrofluorimetric Method for Estimation of Idelalisib in Bulk and in Formulation. Zhurnal Prikladnoii Spektroskopii. 2023;90(4):655.
Views: 127
Email this article 