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Eco-Friendly UV Spectroscopic Method for Precise Quantification of Daprodustat in Pharmaceuticals
Shreya Deshmukh,
Priti Mohite,
Shreyas Talim,
Yash Jaiswal,
Dhrruv Shah,
Aditya Umrethwala,
Sanjay Sharma Abstract
Daprodustat is a new hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) and a novel med-
ication for treating chronic kidney disease anaemia. Daprodustat boosts endogenous erythropoietin produc-
tion, regulates iron metabolism, and is an alternative erythropoiesis-stimulating agent. The aim of this study is to develop and validate a simple, accurate, and environmentally friendly ultraviolet (UV) spectroscopic method for the quantitative analysis of daprodustat in pharmaceutical formulations. The UV spectrophotometric method was prepared using methanol as the solvent and validated according to the International Council for Harmonisation (ICH) Q2 (R2) guidelines. The process was tested for linearity, precision, accuracy, robustness, limit of detection (LOD), and quantification (LOQ). Daprodustat showed maximum absorbance λmax = 261.45 nm in methanol. The linearity range was 4–16 µg/mL, with a regression equation of y = 0.0577x + 0.0477 and a correlation coefficient R2 = 0.9983. The procedure demonstrated excellent precision (relative standard deviation (% RSD) < 2%) and recovery at 98–99%. The LOD and LOQ were 0.672 µg/mL and 2.0 µg/mL, respectively. The new UV spectrophotometric method for quantifying daprodustat in solid dispersions proved simple, accurate, and precise. Environmental sustainability was assessed using Analytical GREEness (AGREE) and the Green Analytical Procedure Index (GAPI). Accordingly, this validated UV spectroscopic method can be effectively used for routine quality control analysis of daprodustat in solid dispersions, providing a cost-effective and sustainable approach to analytical evaluation.
About the Authors
Shreya Deshmukh
SVKM’s NMIMS (Deemed to be University)
India
India
Department of Quality Assurance, Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management
Mumbai
Priti Mohite
SVKM’s NMIMS (Deemed to be University)
India
India
Department of Quality Assurance, Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management
Mumbai
Shreyas Talim
SVKM’s NMIMS (Deemed to be University)
India
India
Department of Quality Assurance, Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management
Mumbai
Yash Jaiswal
SVKM’s NMIMS (Deemed to be University)
India
India
Department of Quality Assurance, Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management
Mumbai
Dhrruv Shah
SVKM’s NMIMS (Deemed to be University)
India
India
Department of Quality Assurance, Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management
Mumbai
Aditya Umrethwala
SVKM’s NMIMS (Deemed to be University)
India
India
Department of Quality Assurance, Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management
Mumbai
Sanjay Sharma
SVKM’s NMIMS (Deemed to be University)
India
India
Department of Quality Assurance, Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management
Mumbai
References
1. R. Bissinger, L. Schaefer, B. N. Bohnert, A. Schork, S. Hoerber, A. Peter, et al., Kidney Int. Rep. (2025).
2. K. L. Johansen, A. R. Cobitz, A. K. Singh, I. C. Macdougall, R. D. Lopes, G. T. Obrador, et al., Kidney Int. Rep., 103, No. 6, 1180–1192 (2023).
3. J. L. Ariazi, K. J. Duffy, D. F. Adams, D. M. Fitch, L. Luo, M. Pappalardi, et al., J. Pharm. Exp. Ther., 363, No. 3, 336–347 (2017).
4. B. Cizman, A. P. Sykes, G. Paul, S. Zeig, A. R. Cobitz, Kidney Int. Rep., 3, No. 4, 841–850 (2018).
5. Y. Machida, T. Iwai, K. Kabei, T. Naganuma, J. Uchida, Transplant Proc., 56, No. 3, 534–539 (2024).
6. M. Philip, A. K. Karakkakal, M. B. Subhahar, T. K. Karatt, B. Mathew, Z. Perwad, Drug Test Anal., 14, No. 2, 317–348 (2022).
7. N. S. Sanghani, V. H. Haase, Adv. Chronic Kidney Dis., 26, No. 4, 253–266 (2019).
8. Q. Zheng, P. Zhang, H. Yang, Y. Geng, J. Tang, Y. Kang, et al., Heliyon, 9, No. 4 (2023).
9. V. J. Patel, A. Joharapurkar, S. G. Kshirsagar, M. S. Patel, H. H. Savsani, H. S. Dodiya, et al., Toxic. Appl. Pharm., 483, 116832 (2024).
10. S. Dhillon, Drugs, 80, No. 14, 1491(1–7) (2020).
11. K. M. Mahar, B. C. Shaddinger, B. Ramanjineyulu, S. Andrews, S. Caltabiano, A. C. Lindsay, et al., Clin. Pharm. Drug Dev., 11, No. 5, 562–575 (2022).
12. A. K. Singh, B. Cizman, K. Carroll, J. V. McMurray, V. Perkovic, V. Jha, et al., JAMA Int. Med., 182, No. 6, 592 (2022).
13. T. Nakai, D. Saigusa, K. Kato, T. Fukuuchi, S. Koshiba, M. Yamamoto, et al., Life Sci., 346, 122641 (2024).
14. M. Mazzarino, I. Perretti, C. Stacchini, F. Comunità, X. De La Torre, F. Botrè, J. Anal. Toxic., 45, No. 2, 184–194 (2021).
15. A. Cetinkaya, S. I. Kaya, S. A. Ozkan, TrAC Trends Anal. Chem., 168, 117330 (2023).
16. N. D. Anastas, J. C. Warner, Chem. Health Saf., 12, No. 2, 9–13 (2005).
17. V. N. Bhukya, D. P. Beda, K. S. Gubbiyappa, R. Pathuri, Green Anal. Chem., 100105 (2024).
18. S. G. Elsheikh, A. M. E. Hassan, Y. M. Fayez, S. S. El-Mosallamy, BMC Chem., 17, No. 1, 38 (2023).
19. F. Mestre-Manrique, R. Payà-Pou, M. Beneito-Cambra, E. F. Simó-Alfonso, E. J. Carrasco-Correa, Adv. Sample Preparation, 100062 (2023).
20. A. Mostafa, RSC Adv. Roy. Soc. Chem., 19658–19679 (2024).
21. G. Cremasco, A. T. Sutton, C. S. Funari, D. R. Arrua, K. J. Dussan, E. F. Hilder, et al., Molecules, 29, No. 13, 3034 (2024).
22. H. Shaaban, Microchem. J., 184 (2023).
23. J. Płotka-Wasylka, Talanta, 181, 204–209 (2018).
24. M. Locatelli, A. Kabir, M. Perrucci, S. Ulusoy, H. I. Ulusoy, I. Ali, Adv. Sample Preparation, 100068 (2023).
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For citations:
Deshmukh Sh., Mohite P., Talim Sh., Jaiswal Ya., Shah D., Umrethwala A., Sharma S. Eco-Friendly UV Spectroscopic Method for Precise Quantification of Daprodustat in Pharmaceuticals. Zhurnal Prikladnoii Spektroskopii. 2026;93(1):141/1-141/8.
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