A bioanalytically validated RP-HPLC method for simultaneous quantification of rivaroxaban, paracetamol, and ceftriaxone in human plasma: a combination used for COVID-19 management.
Journal
Scientific reports
ISSN: 2045-2322
Titre abrégé: Sci Rep
Pays: England
ID NLM: 101563288
Informations de publication
Date de publication:
28 Oct 2024
28 Oct 2024
Historique:
received:
26
04
2024
accepted:
08
10
2024
medline:
28
10
2024
pubmed:
28
10
2024
entrez:
28
10
2024
Statut:
epublish
Résumé
Rivaroxaban is a direct oral anticoagulant medication that has been found to be beneficial for the management of thromboembolic events linked to the Corona virus disease 2019 (COVID-19) pandemic, which has resulted in more than 6 million deaths worldwide. Hence, a sensitive, selective, and green bioanalytically validated method was developed using RP-HPLC coupled with DAD for the simultaneous determination of rivaroxaban in human plasma, and two co-administered drugs, namely, paracetamol, an analgesic, and ceftriaxone, an antibiotic, that are used in the management of COVID-19. An Exsil 100 ODS C18 column (250 × 4.6 mm, 5 μm) was used as the stationary phase, and acetonitrile: water: methanol at a ratio of 60:30:10 (v/v/v) was used in isocratic mode as the mobile phase with a flow rate of 0.7 ml/min. The method was validated over a concentration range of 0.1-10.0 µg/mL for rivaroxaban, and 1.0-15.0 µg/mL for paracetamol and ceftriaxone. The lower limits of detection (LLODs) were found to be 0.03, 0.32, and 0.32 µg/ml for rivaroxaban, paracetamol, and ceftriaxone, respectively. Moreover, the lower limits of quantitation (LLOQs) were found to be 0.1, 0.96, and 0.98 µg/ml. The developed method showed excellent accuracy and precision for the determination of the aforementioned drugs. Four metrics were used to evaluate the greenness of the developed method. The results revealed that the suggested method is green, with values of 81 and 0.6 for the analytical eco-scale and analytical greenness assessment (AGREE), respectively.
Identifiants
pubmed: 39463416
doi: 10.1038/s41598-024-75729-y
pii: 10.1038/s41598-024-75729-y
doi:
Substances chimiques
Ceftriaxone
75J73V1629
Rivaroxaban
9NDF7JZ4M3
Acetaminophen
362O9ITL9D
Anti-Bacterial Agents
0
Types de publication
Journal Article
Validation Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
25693Informations de copyright
© 2024. The Author(s).
Références
Harapan, H., Itoh, N.,Yufika,A., et al. Coronavirus disease 2019 (COVID–19): A literature review. J. Infect. Public Health 13(5), 667–673. https://doi.org/10.1016/j.jiph.2020.03.019 (2020).
doi: 10.1016/j.jiph.2020.03.019
pubmed: 32340833
pmcid: 7142680
Ng, J., Liang, Z. and Choong, A. The incidence of pulmonary thromboembolism in COVID–19 patients admitted to the intensive care unit: a meta-analysis and meta-regression of observational studies. J. Intensive Care 9(20), 20. https://doi.org/10.1186/s40560-021-00535-x (2021).
doi: 10.1186/s40560-021-00535-x
pubmed: 33618760
pmcid: 7897892
Bikdeli, B., Madhavan, M., Jimenez, D., et al. COVID–19 and thrombotic or thromboembolic disease: Implications for prevention, antithrombotic therapy, and follow-up: JACC state-of-the-art review. J. Am. Coll. Cardiol. 75 (23), 2950–2973. https://doi.org/10.1016/j.jacc.2020.04.031 (2020).
doi: 10.1016/j.jacc.2020.04.031
pubmed: 32311448
pmcid: 7164881
COVID–19 Treatment Guidelines Panel. Coronavirus Disease 2019 (COVID–19) Treatment Guidelines. National Institutes of Health.
Leal, N., Yu, Y., Chen, Y., et al. Paracetamol is associated with a lower risk of COVID–19 infection and decreased ACE2 protein expression: A retrospective analysis. COVID 1, 218–229. https://doi.org/10.3390/covid1010018 (2021).
Adebisi, Y., Jimoh, N., Ogunkola, I., et al., The use of antibiotics in COVID–19 management: a rapid review of national treatment guidelines in 10 African countries. Trop. Med. Health 49(1), 51. https://doi.org/10.1186/s41182-021-00344-w (2021).
doi: 10.1186/s41182-021-00344-w
pubmed: 34162445
pmcid: 8220112
Lories, I., Mostafa, A. and Girges,M., High performance liquid chromatography, TLC densitometry, first derivative and first derivative ratio spectrophotometry for determination of rivaroxaban and its alkaline degradates in bulk powder and its tablets. J. Chromatogr. Sep. Tech.., 4(8), 1–6. https://doi.org/10.4172/2157-7064.1000202 (2013).
doi: 10.4172/2157-7064.1000202
Schmitz, E., Boonen, K., van den Heuvel, D., et al., Determination of dabigatran, rivaroxaban and apixaban by ultra-performance liquid chromatography – tandem mass spectrometry (UPLC‐MS/MS) and coagulation assays for therapy monitoring of novel direct oral anticoagulants. J. Thromb. Haemost. 12(10), 1636–1646. https://doi.org/10.1111/jth.12702 (2014).
doi: 10.1111/jth.12702
pubmed: 25142183
Iqbal, M., Khalil, N., Imam, F. et al., A validated high-throughput UHPLC-MS/MS assay for accurate determination of rivaroxaban in plasma sample. J. Thromb. Haemost. 39, 79–88. DOI: https://doi.org/10.1007/s11239-014-1121-2 (2015).
doi: 10.1007/s11239-014-1121-2
Rohde, G., Determination of rivaroxaban – a novel, oral, direct factor xa inhibitor – in human plasma by high-performance liquid chromatography–tandem mass spectrometry. J. Chromatogr. B, 872(1–2), 43–50. DOI: https://doi.org/10.1016/j.jchromb.2008.07.015 (2008).
doi: 10.1016/j.jchromb.2008.07.015
Korostelev, M., Bihan, K., Ferreol, L., et al., Simultaneous determination of rivaroxaban and dabigatran levels in human plasma by high-performance liquid chromatography–tandem mass spectrometry. J. Pharm. Biomed. Anal. 100, 230–235. https://doi.org/10.1016/j.jpba.2014.08.011 (2014).
doi: 10.1016/j.jpba.2014.08.011
pubmed: 25173108
Çelebier, M., Reçber, T., Koçak, E., et al., Determination of rivaroxaban in human plasma by solid-phase extraction–high performance liquid chromatography.J. Chromatogr. Sci., 54(2), 216–220. https://doi.org/10.1093/chromsci/bmv135 (2016).
doi: 10.1093/chromsci/bmv135
pubmed: 26351327
Al-Obaidy, S., Li-Wan-Po, A., McKiernan, P., et al., Assay of paracetamol and its metabolites in urine, plasma and saliva of children with chronic liver disease. J. Pharm. Biomed. Anal. 13(8), 1033–1039. https://doi.org/10.1016/0731-7085(95)01303-3 (1995).
doi: 10.1016/0731-7085(95)01303-3
pubmed: 8580148
Senyuva, H. and Ozden, T., Simultaneous high-performance liquid chromatographic determination of paracetamol, phenylephrine HCl, and chlorpheniramine maleate in pharmaceutical dosage forms. J. Chromatogr. Sci. 40(2), 97–100. https://doi.org/10.1093/chromsci/40.2.97 (2002).
doi: 10.1093/chromsci/40.2.97
pubmed: 11881712
Nagaralli, B., Jaldappa, S., Babu, G., et al., Liquid chromatographic determination of ceterizine hydrochloride and paracetamol in human plasma and pharmaceutical formulations. Anal. Technol. Biomed Life Sci. 798(1), 49–54. DOI: https://doi.org/10.1016/j.jchromb.2003.08.048 (2003).
Delvadiya, K., Kapara, P., Kimbahune, R., et al., High-performance liquid chromatographic determination of paracetamol, propyphenazone, and caffeine in pharmaceutical formulations Indian. J. Pharm. Educ. Res. 47(4), 65–72. https://doi.org/10.5530/ijper.47.4.9 (2014).
doi: 10.5530/ijper.47.4.9
Kam, R., Chan, M., Ghose, A., et al., Quantitation of paracetamol by liquid chromatography-mass spectrometry in human plasma in support of clinical trial. Future Sci. OA 4 (8), FSO331. https://doi.org/10.4155/fsoa-2018-0039 (2018).
Dargue, R., Grant, I., Nye, L., et al., The analysis of acetaminophen (paracetamol) and seven metabolites in rat, pig and human plasma by U(H)PLC-MS. Bioanalysis 12(7), 485–500. https://doi.org/10.4155/bio-2020-0015 (2020).
Demotes-Mainard, F., Vinçon, G., Jarry, C., et al., Micromethod for determination of ceftriaxone in plasma and urine by high-performance liquid chromatography. J. Pharm. Biomed. Anal., 6(4), 407–413. https://doi.org/10.1016/0731-7085(88)80006-2 (1988).
doi: 10.1016/0731-7085(88)80006-2
pubmed: 16867407
Eric-Jovanovic, S., Agbaba, D., Zivanov-Stakic, D,. et al. HPTLC determination of ceftriaxone, cefixime and cefotaxime in dosage forms. J. Pharm. Biomed. Anal., 18(4), 893–898. https://doi.org/10.1016/S0731-7085(98)00274-X (1998).
doi: 10.1016/S0731-7085(98)00274-X
pubmed: 9919994
Kotani, A., Hirai, J., Hamada, Y., et al., Determination of ceftriaxone concentration in human cerebrospinal fluid by high-performance liquid chromatography with UV detection. J. Chromatogr. B 1124, 161–164. https://doi.org/10.1016/j.jchromb.2019.06.008 (2019).
doi: 10.1016/j.jchromb.2019.06.008
Narimani, S. and Samadi, N., Rapid trace analysis of ceftriaxone using new fluorescent carbon dots as a highly sensitive turn-off nanoprobe. Microchem. J. 168, 106372. https://doi.org/10.1016/j.microc.2021.106372 (2021).
doi: 10.1016/j.microc.2021.106372
Xiao, C., Zhang, X., Wang, W., et al., Developing an improved UHPLC method for impurity profile analysis of ceftriaxone using analytical quality by design. Anal. Methods 15(5), 639–647. DOI: https://doi.org/10.1039/D2AY02016E (2023).
doi: 10.1039/D2AY02016E
pubmed: 36651613
Bioanalytical Method Validation Guidance for Industry. Food and Drug Administration, HHS., 83(99), 23690–23691 (2018).
Selimoğlu, F. and Pinarcik, N., Spectrophotometric quantification of paracetamol and tramadol hydrochloride by chemometric calibration methods. Turk. J. Chem. 47(3), 633–645. https://doi.org/10.55730/1300-0527.3566 (2023).
doi: 10.55730/1300-0527.3566
pubmed: 37529219
pmcid: 10387862
Yabré, M., Ferey, L., Somé, I., et al., Greening reversed-phase liquid chromatography methods using alternative solvents for pharmaceutical analysis. Molecules 23(5), 1065. https://doi.org/10.3390/molecules23051065 (2018).
doi: 10.3390/molecules23051065
pubmed: 29724076
pmcid: 6100308
El-Maraghy, C. and Lamie, N., Three smart spectrophotometric methods for resolution of severely overlapped binary mixture of Ibuprofen and Paracetamol in pharmaceutical dosage form. BMC Chem. 13(1), 99. DOI: https://doi.org/10.1186/s13065-019-0618-3 (2019).
doi: 10.1186/s13065-019-0618-3
pubmed: 31406964
pmcid: 6683492
Kodipyaka, S., Pola, R., Yenumula, P., et al., Development and validation of bio-analytical method for the quantitative estimation of rivaroxaban by using UV spectrophotometry. World J. Pharm. Sci. 8(2), 38–43 (2020).
Dew, L., Djoko Wahyono, D., Puspitasari, I., et al., Validation of simple spectrophotometric method for determination of ceftriaxone in human plasma. Int. J. Res. Pharm. Sci 11((SPL 4)), 1645–164.9. https://doi.org/10.26452/ijrps.v11iSPL4.4351 (2020).
Tsai, T., Cheng, F., Hung, L., et al., Determination of unbound ceftriaxone in rat blood by on-line microdialysis and microbore liquid chromatography. Int. J. Pharm., 193(1), 21–26. https://doi.org/10.1016/S0378-5173(99)00309-9 (1999).
doi: 10.1016/S0378-5173(99)00309-9
pubmed: 10581418
Guidance, R., Validation of Chromatographic Methods. Center for Drug Evaluation and Research (CDER), 1994. 2
Ahmed, A., Gamal, M., Naguib, I., et al., Environmental impact of the reported chromatographic methods for the determination of the first FDA-Approved therapy for COVID–19 Patients, Remdesivir: A comparative study. Microchem. J. 176, 107242. https://doi.org/10.1016/j.microc.2022.107242 (2022).
doi: 10.1016/j.microc.2022.107242
pmcid: 8801062
Keith, L., Gron, L. and Young, J., Green analytical methodologies. Chem. Rev. 107(6), 2695–2708. https://doi.org/10.1021/cr068359e (2007).
doi: 10.1021/cr068359e
pubmed: 17521200
Code of Federal Regulations, Protection of Environment, Identification and Listing of Hazardous Waste, Environmental Protection Agency (EPA) ( 2016).
Płotka-Wasylka, J., A new tool for the evaluation of the analytical procedure: Green Analytical Procedure Index. Talanta 181, 204–209. https://doi.org/10.1016/j.talanta.2018.01.013 (2018).
doi: 10.1016/j.talanta.2018.01.013
pubmed: 29426502
Trabik, Y., Ismail, R., Farid, M., et al. Microfabricated potentiometric sensor based on a carbon nanotube transducer layer for selective Bosentan determination. Rev. Anal. Chem., 43(1). https://doi.org/10.1515/revac-2023-0071 (2024).
Pena-Pereira, F., Wojnowski, W. and Tobiszewski, M., AGREE—Analytical GREEnness metric approach and software. Anal. Chem., 92(14), 10076–10082. https://doi.org/10.1021/acs.analchem.0c01887 (2020).
doi: 10.1021/acs.analchem.0c01887
pubmed: 32538619
pmcid: 7588019
Gamal, M., Naguib, A., Pada, D., et al., Comparative study of four greenness assessment tools for selection of greenest analytical method for assay of hyoscine N-butyl bromide. Anal. Methods 13(3), 369–380. DOI: https://doi.org/10.1039/D0AY02169E (2024).
doi: 10.1039/D0AY02169E
pubmed: 33404016