RP-HPLC Method for the Quantification of Impurities in Etelcalcetide Injection and a Comparative Characterization Study of In-House Samples of Etelcalcetide Injection with Reference-Listed Drug Samples

Sivaji Maganti; Suryakala Duvvuri; Srivathsa Degekar Gouni; Pavani Kadupu; M. Bhaskara Praveen Varma

doi:10.14233/ajchem.2025.33486

Issue

Vol. 37 No. 4 (2025): Vol 37 Issue 4, 2025

Issue Published : 29 March 2025

This work is licensed under a Creative Commons Attribution 4.0 International License.

RP-HPLC Method for the Quantification of Impurities in Etelcalcetide Injection and a Comparative Characterization Study of In-House Samples of Etelcalcetide Injection with Reference-Listed Drug Samples

https://doi.org/10.14233/ajchem.2025.33486

Sivaji Maganti

Department of Chemistry, GITAM Deemed to be University, Visakhapatnam-530045, India; Eugia Pharma Specialities Ltd, R & D Centre, Pashamylaram, Patancheru, Medak-502307, India

https://orcid.org/0009-0009-2232-2872

Suryakala Duvvuri

Department of Chemistry, GITAM Deemed to be University, Visakhapatnam-530045, India

https://orcid.org/0000-0001-7964-1764

Srivathsa Degekar Gouni

Eugia Pharma Specialities Ltd, R & D Centre, Pashamylaram, Patancheru, Medak-502307, India; Department of Chemistry, Koneru Lakshmaiah Education Foundation, Green Fields, Vaddeswaram-522302, India

https://orcid.org/0009-0004-7348-1738

Pavani Kadupu

Eugia Pharma Specialities Ltd, R & D Centre, Pashamylaram, Patancheru, Medak-502307, India

https://orcid.org/0009-0005-1490-5243

M. Bhaskara Praveen Varma

Eugia Pharma Specialities Ltd, R & D Centre, Pashamylaram, Patancheru, Medak-502307, India

https://orcid.org/0009-0006-0912-8432

Corresponding Author(s) : Suryakala Duvvuri

sduvvuri@gitam.edu

Asian Journal of Chemistry, Vol. 37 No. 4 (2025): Vol 37 Issue 4, 2025
Article Published : 29 March 2025

Abstract

In present study, an accurate and simple reversed phase-high performance liquid chromatography (RP-HPLC) method for the determination of potential impurities resulting from etelcalcetide injection was validated. An Ace Excel 3 C18 amide column with 100% 0.1 M sodium perchlorate (pH 2.0) buffer (100%) was used as mobile phase A and a 60:10 (%v/v) ratio of acetonitrile and 0.1 M sodium perchlorate (pH 2.0) was used as mobile phase B. The wavelength detection performed at 210 nm. Etelcalcetide injection was subjected to thermal, photolytic, acid, base, and peroxide degradation conditions, which were studied using the current methodology. The method was validated as per the International Council for Harmonization guideline (ICH). Consistent recoveries were obtained for all the impurities of etelcalcetide between 85% and 105%. Furthermore, comparative characterization studies and impurity profiling were successfully performed for in-house samples of etelcalcetide with reference-listed drug (RLD) samples through circular dichroism (CD), Fourier transform infrared (FTIR), size exclusion chromatography-high performance liquid chromatography (SEC-HPLC) and liquid chromatography-high resolution mass spectrometry (LC-HRMS), results indicates that found similar in both in-house and RLD samples.

Keywords

Etelcalcetide injection Circular dichroism SEC-HPLC

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Maganti, S.; Duvvuri, S.; Gouni, S. D.; Kadupu, P.; Varma, M. B. P. RP-HPLC Method for the Quantification of Impurities in Etelcalcetide Injection and a Comparative Characterization Study of In-House Samples of Etelcalcetide Injection With Reference-Listed Drug Samples. ajc 2025, 37, 968-974.

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References

A. Galassi, P. Ciceri, E. Fasulo, S. Carugo, G. Cianciolo and M. Cozzolino, Drugs Aging, 36, 885 (2019); https://doi.org/10.1007/s40266-019-00696-3
S.M. Mousavi Movahed, S.S. Beladi Mousavi and M. Faramarzi, J. Parathyr. Dis., 6, 64 (2017); https://doi.org/10.15171/jpd.2018.20
A. Owda, H. Elhwairis, S. Narra, H. Towery and S. Osama, Ren. Fail., 25, 595 (2003); https://doi.org/10.1081/JDI-120022551
Z. Xiang, M. Wang, C. Miao, D. Jin and H. Wang, Front. Pharmacol., 13, 1020858 (2022); https://doi.org/10.3389/fphar.2022.1020858
G. Díaz-Soto, A. Rocher, C. García-Rodríguez, L. Núñez and C. Villalobos, Int. Rev. Cell Mol. Biol., 327, 321 (2016); https://doi.org/10.1016/bs.ircmb.2016.05.004
L. Yu, J.E. Tomlinson, S.T. Alexander, K. Hensley, C.-Y. Han, D. Dwyer, M. Stolina, C. Dean Jr., W.G. Goodman, W.G. Richards and X. Li, Calcif. Tissue Int., 101, 641 (2017); https://doi.org/10.1007/s00223-017-0319-7
S.C. Ren, N. Mao, S. Yi, X. Ma, J.Q. Zou, X. Tang and J.M. Fan, Aging Dis., 13, 673 (2022); https://doi.org/10.14336/AD.2021.1024
J. Ye, G. Deng and F. Gao, Drug Des. Devel. Ther., 12, 901 (2018); https://doi.org/10.2147/DDDT.S160223
A. Baruch and D. Maclean, Discovery of Etelcalcetide for the Treatment of Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease, In: Successful Drug Discovery, Wiley, vol. 4, pp. 131-152 (2019); https://doi.org/10.1002/9783527814695.ch5
K. Sharma, K.K. Sharma, A. Sharma and R. Jain, Drug Discov. Today, 28, 103464 (2023); https://doi.org/10.1016/j.drudis.2022.103464
R. Pawar, S. Tivari, D. Panchani and J. Makasana, Separ. Sci. Plus, 7, e202400015 (2024); https://doi.org/10.1002/sscp.202400015
M.B. Savadkouhi, H. Vahidi, A.M. Ayatollahi, S. Hooshfar and F. Kobarfard, Iran. J. Pharm. Res., 16, 490 (2017).
J. Kaliyaperumal, P. Padarthi, K. Rangasamy and E. Namasivayam, Chem. Sci., 3, 1078 (2014); https://doi.org/10.7598/cst2014.809
C. T. Mant, Y. Chen, Z. Yan, T. V. Popa, J. M. Kovacs, J. B. Mills and R. S. Hodges, in eds.: G.B. Fields, HPLC Analysis and Purification of Peptides, In: Peptide Characterization and Application Protocols, Humana Press, vol. 386, p. 3 (2017).
A.K. Kuril and K. Saravanan, Int. J. Pharm. Sci. Drug Res., 16, 1 (2024); https://doi.org/10.5281/zenodo.13629324
L. Wang, N. Wang, W. Zhang, X. Cheng, Z. Yan, G. Shao, X. Wang, R. Wang and C. Fu, Signal Transduct. Target. Ther., 7, 48 (2022); https://doi.org/10.1038/s41392-022-00904-4
https://www.ema.europa.eu/en/documents/scientificguideline/ich-guideline-Q2(R2)validation-analytical-procedures-step-2b_en.pdf