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Development and Validation of Novel Rapid Stability Indicating Mass Compatible UPLC Method for the Simultaneous Estimation of Assay and Related Substances of Remdesivir in Bulk and Injectable Dosage Form
Corresponding Author(s) : K.R.S. Prasad
Asian Journal of Chemistry,
Vol. 34 No. 11 (2022): Vol 34 Issue 11, 2022
Abstract
Developed and validated a simple, rapid, new mass compatible reverse phase ultra-performance liquid chromatography (UPLC) method for the simultaneous estimation of assay and related substance of remdesivir in bulk and injectable dosage form. The developed method is capable of separating all the potential process and degradation impurities within 15 min. Chromatography was carried out using Waters Acquity BEH C18 column (50 mm length, 2.1 mm internal diameter and 1.7 μ particle size) with gradient elution. Ghost buster column (30 mm length, 2.1 mm internal diameter) was used as inline filter to suppress the response of peaks originating from mobile phase. Mobile phase A composed of 10 mM ammonium acetate buffer pH 3.5 and acetonitrile in the ratio of 90:10 v/v and mobile phase B composed of 10 mM ammonium acetate buffer pH 3.5 and acetonitrile in the ratio of 10:90 v/v. The flow rate of the mobile phase was set at 0.35 mL/min and the column temperature was maintained at 35 ºC. The detection was carried out using UV detector at 245 and 270 nm. Method validation was performed according to ICH guidelines. The validated method is simple, rapid, mass compatible, economical, specific, accurate, linear, precise, rugged, sensitive, robust and stability indicating. This method can be employed for the simultaneous estimation of assay and related substance of remdesivir in bulk and injectable dosage forms at quality control laboratories of pharmaceutical industries.
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References
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J.J. Malin, I. Suarez, V. Priesner, G. Fatkenheuer and J. Rybniker, Clin. Microbiol. Rev., 34, e00162-20 (2020); https://doi.org/10.1128/CMR.00162-20
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M. Davies, V. Osborne, S. Lane, D. Roy, S. Dhanda, A. Evans and S. Shakir, Drug Saf., 43, 645 (2020); https://doi.org/10.1007/s40264-020-00952-1
C.J. Gordon, E.P. Tchesnokov, E. Woolner, J.K. Perry, J.Y. Feng, D.P. Porter and M. Götte, J. Biol. Chem., 295, 6785 (2020); https://doi.org/10.1074/jbc.RA120.013679
FDA news release, FDA Approves First Treatment for COVID-19, https://www.fda.gov/news-events/press-announcements/fda-approvesfirst-treatment-covid-19.
R.T. Eastman, J.S. Roth, K.R. Brimacombe, A. Simeonov, M. Shen, S. Patnaik and M.D. Hall, ACS Cent. Sci., 6, 672 (2020); https://doi.org/10.1021/acscentsci.0c00489
Drug bank, Remdesivir. https://www.drugbank.ca/drugs/DB14761 (accessed December 19, 2021).
Y. Pashaei, Drug Discov. Ther., 14, 273 (2020); https://doi.org/10.5582/ddt.2020.03097
J.-C. Alvarez, P. Moine, I. Etting, D. Annane and I.A. Larabi, Clin. Chem. Lab. Med., 58, 1461 (2020); https://doi.org/10.1515/cclm-2020-0612
V. Avataneo, A. de Nicolo, J. Cusato, M. Antonucci, A. Manca, A. Palermiti, C. Waitt, S. Walimbwa, M. Lamorde, G. di Perri and A. D’Avolio, J. Antimicrob. Chemother., 75, 1772 (2020); https://doi.org/10.1093/jac/dkaa152
P. Du, G. Wang, S. Yang, P. Li and L. Liu, Anal. Bioanal. Chem., 413, 5811 (2021); https://doi.org/10.1007/s00216-021-03561-8
R. Nguyen, J.C. Goodell, P.S. Shankarappa, S. Zimmerman, T. Yin, C.J. Peer and W.D. Figg, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 1171, 122641 (2021); https://doi.org/10.1016/j.jchromb.2021.122641
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International Conference on Harmonisation, Harmonised Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology Q2(R1), Current Step 4 version, Parent Guideline dated 27 October 1994, (Complementary Guideline on Methodology dated 6 November 1996 incorporated in November 2005).
L.R. Snyder, J.J. Kirkland and J.L. Glajch. Practical HPLC Method Development, Second Edition, John Wiley & Sons, Inc. (1997).
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