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Vol. 35 No. 6 (2023): Vol 35 Issue 6, 2023

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Analytical Lifecycle Management (ALM) and Analytical Quality by Design (AQbD) based Analytical Method Development for Separation of Related Substances in Amodiaquine Hydrochloride along with its Degradation Products and Structural Elucidation by LC-Quadru

https://doi.org/10.14233/ajchem.2023.27870
Jaya Raju Cheerla
Department of Chemistry, Koneru Lakshmaiah Education Foundation, Vaddeswaram-522302, India Analytical Research and Development, United States Pharmacopeial Convention-India (P) Ltd., Plot No. D6 & D8, IKP, Genome Valley, Shameerpet, Hyderabad-500101, India
https://orcid.org/0000-0002-9889-2013
T. Bhaskara Rao
Department of Chemistry, Koneru Lakshmaiah Education Foundation, Vaddeswaram-522302, India
https://orcid.org/0000-0002-0632-4159
P. Sanath Kumar Goud
Analytical Research and Development, United States Pharmacopeial Convention-India (P) Ltd., Plot No. D6 & D8, IKP, Genome Valley, Shameerpet, Hyderabad-500101, India

Corresponding Author(s) : Jaya Raju Cheerla

jayaraju007@gmail.com

Asian Journal of Chemistry, Vol. 35 No. 6 (2023): Vol 35 Issue 6, 2023

Abstract

The current study aimed to develop a robust, regulatory-flexible, stability-indicating ultra high performance liquid chromatography (UHPLC) analytical procedure compatible with mass spectrometry for the determination of impurities in amodiaquine hydrochloride using analytical lifecycle management (ALM) and analytical quality by design (AQbD) principles. The analytical target profile (ATP) and critical method attributes (CMAs) for the analytical method were identified. The pH of the mobile phase, flow rate and column oven temperature were identified as critical method parameters (CMPs) through risk assessment studies and they were screened and optimized using the design of experiments (DoE) to generate the design space (DS). Finally, all the impurities were well separated in a 15 min run time by using an Acquity UPLC BEH-C18 column with 20 mM ammonium acetate pH 8.0 as mobile phase A and acetonitrile as mobile phase B with a gradient program of time (min), % of B: 0/15, 1.0/15, 9/55, 12/55, 12.1/15 and 15/15. The flow rate was 0.3 mL min-1 and the column oven temperature were 30 ºC. Evaluated the robustness of the developed analytical method. Degradation products obtained from the forced degradation studies are well separated from process impurities and main compound. Based on the stress studies, impurity-3 was identified as a key degradation product in base degradation, while DP-1, impurity-3, DP-2, DP-3 and DP-4 were in the oxidative degradation. Total 9 impurities out of 4 process related and 5 degradation impurities were well separated in the developed method. Used the same method to LC coupled tandem mass spectrometer for separation and structure elucidation of degradation products. The method validation was carried out in accordance with ICH Q2 (R1) and USP <1225> guidelines.

Keywords

Amodiaquine hydrochloride Design of experiments Method operable design region Design space UHPLC LC-Q-ToF MS
Cheerla, J. R., Rao, T. B., & Goud, P. S. K. (2023). Analytical Lifecycle Management (ALM) and Analytical Quality by Design (AQbD) based Analytical Method Development for Separation of Related Substances in Amodiaquine Hydrochloride along with its Degradation Products and Structural Elucidation by LC-Quadru. Asian Journal of Chemistry, 35(6), 1379–1390. https://doi.org/10.14233/ajchem.2023.27870
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References
  1. https://pubchem.ncbi.nlm.nih.gov/compound/Amodiaquine
  2. Y. Le Vaillant, C. Brenier, Y. Grange, A. Nicolas, P.A. Bonnet, M. Ciss, L.R. Massing-Bias, P. Rakotomanga, B. Koumaré, A. Mahly, M. Absi, M.H. Loueslati and D. Chauvey, Chromatographia, 75, 617 (2012); https://doi.org/10.1007/s10337-012-2241-5
  3. N.C. Amin, M.D. Blanchin, M. Aké, J. Montels and H. Fabre, Malar. J., 11, 149 (2012); https://doi.org/10.1186/1475-2875-11-149
  4. M.H. Odedara, S.D. Faldu and K.P. Dadhania, J. Pharm. Sci. Biosci. Res., 2, 114 (2012).
  5. S.V. Deshpande, C.P. Patel, M.T. Mohite and J.K. Suthar, Emer. Life Sci. Res., 2, 26 (2016).
  6. C. Lamalle, R.D.A. Marini, B. Debrus, P. Lebrun, J. Crommen, P. Hubert, A.-C. Servais and M. Fillet, Electrophorosis, 33, 1669 (2012); https://doi.org/10.1002/elps.201100621
  7. L. Hoellein and U. Holzgrabe, J. Pharm. Biomed. Anal., 98, 434 (2014); https://doi.org/10.1016/j.jpba.2014.06.013
  8. J.R. Ch and R.T. Bhaskara, J. Liq. Chromatogr. Rel. Technol., 41, 955 (2018); https://doi.org/10.1080/10826076.2018.1492936
  9. E.A. Penna, J.C.Q. de Souza, M.A.L. de Oliveira and P.R. Chellini, Anal. Methods, 13, 4557 (2021); https://doi.org/10.1039/D1AY01173A
  10. S. Ganta and S. Vidyadhara, J. Glob. Trends Pharm. Sci., 8, 3584 (2017).
  11. E.M. Hodel, B. Zanolari, T. Mercier, J. Biollaz, J. Keiser, P. Olliaro, B. Genton and L.A. Decosterd, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 877, 867 (2009); https://doi.org/10.1016/j.jchromb.2009.02.006
  12. X. Chen, P. Deng, X. Dai and D. Zhong, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 860, 18 (2007); https://doi.org/10.1016/j.jchromb.2007.09.040
  13. J. Gallay, S. Prod’hom, T. Mercier, C. Bardinet, D. Spaggiari, E. Pothin, T. Buclin, B. Genton and L.A. Decosterd, J. Pharm. Biomed. Anal., 154, 263 (2018); https://doi.org/10.1016/j.jpba.2018.01.017
  14. J.-P. Mufusama, K.N. Ioset, D. Feineis, L. Hoellein, U. Holzgrabe and G. Bringmann, Drug Test. Anal., 10, 1599 (2018); https://doi.org/10.1002/dta.2420
  15. V.G. Dongre, P.P. Karmuse, P.D. Ghugare, S.K. Kanojiya and S. Rawal, Rapid Commun. Mass Spectrom., 22, 2227 (2008); https://doi.org/10.1002/rcm.3605
  16. M. Yabre, L. Ferey, T.I. Somé, G. Sivadier and K. Gaudin, J. Pharm. Biomed. Anal., 190, 113507 (2020); https://doi.org/10.1016/j.jpba.2020.113507
  17. J.R. Cheerla, R.T. Bhaskara and P.S.K. Goud, J. Xi’an Shiyou Univ., Nat. Sci. Educ., 18, 953 (2022).
  18. C. Charrier, G. Bertho, O. Petigny, P. Moneton and R. Azerad, J. Pharm. Biomed. Anal., 81-82, 20 (2013); https://doi.org/10.1016/j.jpba.2013.03.009
  19. D. Swain, A.S. Yadav, C. Sasapu, V. Akula and G. Samanthula, Microchem. J., 155, 104657 (2020); https://doi.org/10.1016/j.microc.2020.104657
  20. V. Dhiman, D. Singh, M.K. Ladumor and S. Singh, J. Sep. Sci., 40, 4530 (2017); https://doi.org/10.1002/jssc.201700904
  21. S.G. Hiriyanna, K. Basavaiah, P.S.K. Goud, V. Dhayanithi, K. Raju and H.N. Pati, Acta Chromatogr., 20, 81 (2008); https://doi.org/10.1556/AChrom.20.2008.1.7
  22. C.K. Raju, A.K. Pandey, G.S.K. Ghosh, A. Pola, S.K.P. Goud, M.A. Jaywant and S.G. Navalgund, J. Pharm. Biomed. Anal., 140, 1 (2017); https://doi.org/10.1016/j.jpba.2017.02.044
  23. A. Kumar Pandey, R. Rapolu, C.K. Raju, G. Sasalamari, S.K. Goud, A. Awasthi, S.G. Navalgund and K.V. Surendranath, J. Pharm. Biomed. Anal., 120, 65 (2016); https://doi.org/10.1016/j.jpba.2015.11.037
  24. C.K. Raju, A.K. Pandey, K. Ghosh, A. Pola, S.K. Goud, M.A. Jaywant, S.G. Navalgund and K.V. Surendranath, J. Pharm. Biomed. Anal., 133, 82 (2017); https://doi.org/10.1016/j.jpba.2016.11.005
  25. The International Pharmacopoeia, WHO Department of Essential Medicines and Health Product, Edn.: 10th (2020).
  26. United States Pharmacopeia, Amodiaquine Hydrochloride, USP43-NF38, p–293.
  27. S.A. Wren and P. Tchelitcheff, J. Chromatogr. A, 1119, 140 (2006); https://doi.org/10.1016/j.chroma.2006.02.052
  28. M.K. Parr and A.H. Schmidt, J. Pharm. Biomed. Anal., 147, 506 (2018); https://doi.org/10.1016/j.jpba.2017.06.020
  29. J. Teng, C. Zhu, J. Lyu, L. Pan, M. Zhang, F. Zhang and H. Wu, J. Pharm. Biomed. Anal., 207, 114417 (2022); https://doi.org/10.1016/j.jpba.2021.114417
  30. S.K. Muchakayala, N.K. Katari, K.K. Saripella, H. Schaaf, V.M. Marisetti, S.K. Ettaboina and V.K. Rekulapally, J. Chromatogr. A, 1679, 463380 (2022); https://doi.org/10.1016/j.chroma.2022.463380
  31. ICH Q14 Guideline “Analytical Procedure Development” draft version, (Endorsed on 24 March 2022).
  32. USP general chapter <1220> “Analytical Procedure Life Cycle”, USPNF 2022 ISSUE 1.
  33. R. Peraman, K. Bhadraya and Y. Padmanabha Reddy, Int. J. Anal. Chem., 2015, 868727 (2015); https://doi.org/10.1155/2015/868727
  34. T. Tome, N. Zigart, Z. Casar and A. Obreza, Org. Process Res. Dev., 23, 1784 (2019); https://doi.org/10.1021/acs.oprd.9b00238
  35. S.S. Panda, R.K.V.V. Bera, S.K. Acharjya, P. Sahoo and S. Beg, Sep. Sci. Plus, 2, 18 (2019); https://doi.org/10.1002/sscp.201800110
  36. C.S. Moreira and F.R. Lourenço, Microchem. J., 154, 104610 (2020); https://doi.org/10.1016/j.microc.2020.104610
  37. S. Schmidtsdorff, J. Neumann, A.H. Schmidt and M.K. Parr, J. Pharm. Biomed. Anal., 197, 113960 (2021); https://doi.org/10.1016/j.jpba.2021.113960
  38. ICH Q2 (R1) Guideline Validation of Analytical Procedures: Text and Methodology, Current Step 4 version, ICH (2005).
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