Eco-friendly
Ultra-high-performance liquid chromatography (UHPLC) with green aqueous-organic
mobile phase was applied for the simultaneous determination of febuxostat (FEB)
and diclofenac (DIC) with the composition of water:ethanol (85:15v/v) utilizing phenomenex Kinetex C18 column (4.6 × 100 mm 2.6 μm), flow rate 1 ml/min andUV detection at 280 nmwith linear ranges of 0.4 - 4.0 μg/mL and 0.5 - 5.0 μg/mL
for FEB and DIC, respectively. The proposed method was also successfully
applied to analyze the two drugs in pharmaceutical dosage form and human
plasma. The results obtained were validated and statistically analyzed and
found to be in accordance with those given by reported methods. Moreover, the
greenness of the developed method is assessed using suitable analytical Eco-Scale
and GAPI toolsand comparison
with the previously published methods have been carried out to indicate the
priority of the proposed method. UHPLC is considered eco-friendly method
regarding uses of safe solvents, simple, accurate and short time of analysis.
References
[1]
Sweetman, S.C. (2011) Martindale: The Complete Drug Reference. 37th Edition, Pharmaceutical Press, London.
[2]
Edwards, N.L. (2009) Febuxostat: A New Treatment for Hyperuricaemia in Gout. Rheumatology, 48, ii15-ii19. https://doi.org/10.1093/rheumatology/kep088
[3]
Becker, M.A., Schumacher, H.R., Espinoza, L.R., Wells, A.F., MacDonald, P.A., Lioyd, E. and Lademacher, C. (2010) The Urate-Lowering Efficacy and Safety of Febuxostat in the Treatment of the Hyperuricemia of Gout: The CONFIRMS Trial. Arthritis Research and Therapy, 12, Article No. R63. https://doi.org/10.1186/ar2978
[4]
Habib, I., Rizk, M., Abou El-Alamin, M.M. and Imam, G.S. (2016) Simultaeous Spectrophotometric Determination of Febuxostat and Diclofenac in Pharmaceutical Dosage Using Chemometrics Methods. European Journal of Biomedical and Pharmaceutical Sciences, 3, 188-195.
[5]
Modi, N.R., Mothalia, C.P., Prajapati, K.R., Parmar, R.R., Shah, V.N. and Shah, D. (2013) Development and Validation of Spectrophotometric Method for Simultaneous Estimation of Diclofenac Potassium and Febuxostat in Tablet Dosage Forms. International Journal of Pharmaceutical Sciences, 4, 268-278.
[6]
Derasari, J.M. and Patel, V.P (2013) Spectrophotometric Determination of Febuxostat and Diclofenac Potassium in Their Combined Dosage form by Simultaneous Equation and First Order Derivative Methods. Asian Journal of Research in Chemistry, 6, 968-972.
[7]
El-Yazbi, F.A, Amin, O.A., El-Kimary, E.I., Khamis, E.F. and Younis, S.E. (2016) HPTLC and Spectrophotometric Estimation of Febuxostat and Diclofenac Potassium in their Combined Tablets. Journal of Chromatographic Science, 54, 1146-1152. https://doi.org/10.1093/chromsci/bmw091
[8]
El-Yazbi, F.A, Amin, O.A., El-Kimary, E.I., Khamis, E.F. and Younis, S.E. (2018) High-Performance Thin-Layer Chromatographic Methods for the Determination of Febuxostat and Febuxostat/Diclofenac Combination in Human Plasma. Journal of Chromatography B, 1086, 89-96. https://doi.org/10.1016/j.jchromb.2018.04.020
[9]
El-Yazbi, F.A., Amin, O.A., El-Kimary, E.I., Khamis, E.F., Younis, S.E, Elkhatib, M.A. and El-Yazbi, A.F. (2019) A Novel HPLC-DAD Method for Simultaneous Determination of Febuxostat and Diclofenac in Biological Samples: Pharmacokinetic Outcomes. Bioanalysis, 11, 41-54. https://doi.org/10.4155/bio-2018-0219
[10]
Vaibhav, S., Mohit, M. and Sadhana, R. (2013) Validation of RP-HPLC for Simultaneous Estimation of Febuxostat and Diclofenac Potassium in Bulk Drug and in BI Layer Tablet Formulation. International Research Journal Pharmacy, 4, 103-106. https://doi.org/10.7897/2230-8407.04921
[11]
The British Pharmacopoeia Commission (2016) The British Pharmacopoeia. Her Majesty’s Stationery Office, London.
[12]
The Directorate for the Quality of Medicines & Healthcare of the Council of Europe (2014) The European Pharmacopeia. 8th Edition, the Council of Europe, Strasbourg.
[13]
United States Pharmacopeial Convention (2011) The United States Pharmacopeia. 33rd Edition, United States Pharmacopeial Convention, Inc., Rockville.
[14]
Koel, M. and Kaljurand, M. (2006) Application of the Principles of Green Chemistry in Analytical Chemistry. Pure and Applied Chemistry, 78, 1993-2002. https://doi.org/10.1351/pac200678111993
[15]
Tobiszewski, M. (2016) Metrics for Green Analytical Chemistry. Analytical Methods, 8, 2993-2999. https://doi.org/10.1039/C6AY00478D
[16]
Korany, M., Mahgoub, H., Haggag, R., Ragab, M. and Elmalla, O. (2017) Green Chemistry: Analytical and Chromatography. Journal of Liquid Chromatography and Related Technologies, 40, 839-852. https://doi.org/10.1080/10826076.2017.1373672
[17]
Piontek, J.C., Zalewski, P., Jelinska, A. and Garbacki, P. (2013) UHPLC: The Greening Face of Liquid Chromatography. Chromatographia, 76, 1429-1437. https://doi.org/10.1007/s10337-013-2434-6
[18]
Gałuszka, A., Migaszewski, Z.M., Konieczka, P. and Namiesnik, J. (2012) Analytical Eco-Scale for Assessing the Greenness of Analytical Procedures. Trends in Analytical Chemistry, 37, 61-72. https://doi.org/10.1016/j.trac.2012.03.013
[19]
Płotka-Wasylka, J. (2018) 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
[20]
Sheldon, R.A. (2012) Fundamentals of Green Chemistry: Efficiency in Reaction Design. Chemical Society Reviews, 41, 1437-1451. https://doi.org/10.1039/C1CS15219J
[21]
Prat, D., Hayler, J. and Wells, A. (2014) A Survey of Solvent Selection Guide. Green Chemistry, 16, 4546-4551. https://doi.org/10.1039/C4GC01149J
[22]
Mohamed, H.M. (2015) Green, Environment-Friendly, Analytical Tools Give Insights in Pharmaceuticals and Cosmetics Analysis. Trends in Analytical Chemistry, 66, 176-192. https://doi.org/10.1016/j.trac.2014.11.010
[23]
International Conference on Harmonization (ICH) (2005) Technical Requirements for the Registration of Pharmaceutical for Human Use, of Analytical Procedures: Text and Methodology Q2 (R1). Geneva.
[24]
Miller, J.C. and Miller, J.N. (2005) Statistics and Chemometrics for Analytical Chemistry. 5th Edition, Pearson Education Limited, Harlow.
[25]
Zhang, M., Di, X., Xu, L., Xu, J., Yang, Y., Jiang, N., Song, L. and Xu, X. (2014) Pharmacokinetics and Pharmacodynamics of Febuxostat under Fasting Conditions in Healthy Individuals. Experimental and Therapeutic Medicine, 7, 393-396. https://doi.org/10.3892/etm.2013.1414
[26]
Riess, W., Stierlin, H., Degen, P., Faigle, J.W., Gerardin, A. and Moppert, J. (2009) Pharmacokinetics and Metabolism of the Anti-Inflammatory Agent Voltaren. Scandinavian Journal of Rheumatology, 7, 17-29. https://doi.org/10.3109/03009747809097212
[27]
Tobiszewski, M., Marc, M., Galuszka, A. and Namiesnik, J. (2015) Green Chemistry Metrics with Special Reference to Green Analytical Chemistry. Molecules, 20, 10928-10946. https://doi.org/10.3390/molecules200610928
