Development and Validation of Montelukast with Grape/Licorice Juices and its Application to Pharmacokinetic Studies by LC/MS
Keywords:
Validation, LC/MS, Grape, Licorice, Pharmacokinetic, Montelukast
Abstract
A simple, rapid and sensitive simultaneous method for validation and determination of Montelukast in rat plasma in the presence of grape and licorice juices has been done by using High Performance Liquid Chromatography–Mass Spectrometry (HPLC/MS). A mixture of (77.5 % methanol, 22.5 % of 0.2% FA in water) was used as a mobile phase, ACE 5 C8 column (50 X 2.1 mm, 5μ), and a flow rate of 0.1 ml/min were used, the auto-sampler injection volume was 5 microliters, and candesartan was used as an internal standard. According to the result obtained, the precision of predicted measurements for Montelukast was good (mean CV % 0.05) of grape on Montelukast Cmax (163.492 ng/ml ±113.27). Neither licorice gives significant decrease in the Montelukast Cmax (143.861ng/ml ±54.52), its only delay the average Montelukast Cmax to half an hour. Even for the AUC, there were no significant difference between Montelukast alone and Montelukast with grape, and Montelukast with licorice (P>0.05). The kinetic data shows that Montelukast plasma level was the same with both combination of Montelukast and grape, and Montelukast and licorice.
References
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Singh, R. R., Rathnam, M. V., 2012. A Stability indicating RPHPLC method for the estimation of Montelukast sodium and Fexofenadine hydrochloride in pharmaceutical preparations. Ind J Pharm Sci 4(2), 135-141.
Sripalakit, P., Kongthong, B., Saraphanchotiwitthaya, A., 2008. A simple bioanalytical assay for determination of montelukast in human plasma- application to a pharmacokinetic study. J Chromatogr B Analyt Technol Biomed Life Sci 869, 38–44. doi:10.1016/j.jchromb.2008.05.017
Tamir, S., Eizenberg, M., Somjen, D., Izrae, S., Vaya, J., 2001., Estrogen-like activity of glabrene and other constituents isolated from licorice root. J Stero Biochem Mol Biol 78(3), 291-298.
Yilmaz, Y., Toledo, R. T., 2004. Major flavonoids in grape seeds and skins: antioxidant capacity of catechin, epicatechin, and gallic acid. J of Agricult and Food Chemistr 52(2), 255-260.
Zhang, Y., Jayaprakasam, B., Seeram, N. P., Olson, L. K., DeWitt, D., Nair, M. G., 2004. Insulin secretion and cyclooxygenase enzyme inhibition by cabernet sauvignon grape skin compounds. J of Agricult and Food Chemistr 52(2), 228-233.
Zhou, D. Y., Du, Q., Li, R. R., Huang, M., Zhang, Q., Wei, G. Z. 2011., Grape seed proanthocyanidin extract attenuates airway inflammation and hyperresponsiveness in a murine model of asthma by down regulating inducible nitric oxide synthase. Planta medica 77(14), 1575-1581.
Amlani, S., McIvor, R.A., 2011., Montelukast in childhood asthma: what is the evidence for its use? Expert Review of Respiratory Medicine 5(1), 17-22.
Bailey, G.D., Malcolm, J., Arnold, O., Spence, J.D., 1998. Grapefruit juice‐drug interactions. Br J Clin Pharmacol. 46, 101– 110.
Bharathi, D.V., Hotha, K.K., Jagadeesh, B., Mullangi, R., Naidu, A., 2009. Quantification of montelukast, selective cysteinyl leukotriene receptor (CysLT1) antagonist in human plasma by liquid chromatography-mass spectrometry- validation and its application to a human pharmacokinetic study. Biomed Chromatogr 23, 804–810. doi:10.1002/bmc.1189
Bista, D., Palaian, S., Shankar, P.R., Prabhu, M.M., Paudel, R., Mishra, P., 2006. Understanding the essentials of drug interactions: A potential need for safe and effective use of drugs. Kathmandu University Medical Journal 4(3), 421-430.
Challah, B. R., Awen, B. Z., Chandu, B. R., Khagga, M., Kotthapalli, C. B., 2010. Method Development and Validation of Montelukast in Human Plasma by HPLC Coupled with ESI-MS/MS: Application to a Bioequivalence Study. Scientia Pharmaceutic 78, 411–422.
Cing, C., Toros S. Z., Gürbüz, M. K., Ince I., Cakli, H., Erdogmus, N., Karasulu, E. Kaya, E., 2013. Effect of grapefruit juice on bioavailability of montelukast. The Laryngoscope. 123(4), 816–819.
Diamant, Z., Mantzouranis, E., Bjermer, L., 2009. Montelukast in the treatment of asthma and beyond. Expert Rev Clin Immunol 5(6), 639-58.
Docherty, J. J., Smith, J. S., Fu, M. M., Stoner, T., Booth, T., 2004. Effect of topically applied resveratrol on cutaneous herpes simplex virus infections in hairless mice. Antiviral Res 61(1), 19-26.
Donnelly, L.E., Newton, R., Kennedy, G.E., 2004. Anti-inflammatory effects of resveratrol in lung epithelial cells: molecular mechanisms. Amer J Physiol Lung Cel Mol Physiol 287(4), L774-L783.
EMA. 2011. Guideline on Bioanalytical Method Validation. EMA, Committee for Medicinal Products for Human Use (CHMP), London, UK (2011).
Hakimuddin, F, Paliyath, G, Meckling, K., 2004. Selective cytotoxicity of a red grape wine flavonoid fraction against MCF-7 cells. Breast Cancer Res Treat 85, 65–79
Hamad, M., Al-Jariri, R., Al Tamimi, L., Abu Dayyih, A., Abu Dayyih, W., Mallah, E., Arafat, T., 2017. Validation and determination of piracetam in rat plasma by using high performance liquid chromatography/UV/VIS spectrometry (HPLC/UV/VIS) in presence of pomegranate and liquorice juices for pharmacokinetic study. Int J Biol Pharmac Allied Sci 6(12), 2431-2449
Hegazy, S.K., Mabrouk, M.M., Elsisi, A.E., Mansour, N.O., 2012. Effect of clarithromycin and fluconazole on the pharmacokinetics of montelukast in human volunteers. Eur J Clin Pharmacol 68(9),1275-80
Ismail, M. Y. M., 2009. Drug-food interactions and role of pharmacist. Asian journal of pharmaceutical and clinical research 2(4), 221-229.
Karonen, T., Filppula, A., Laitila, J., Niemi, M., Neuvonen, P. J., Backman, J. T., 2010. Gemfibrozil markedly increases the plasma concentrations of montelukast: a previously unrecognized role for CYP2C8 in the metabolism of montelukast. Clin Pharmaco Therap 88(2), 223-230.
Li, H.Y., Xu, W., Su, J., Zhang, X., Hu, L.W., Zhang, W.D., 2010. In vitro and in vivo inhibitory effects of glycyrrhetinic acid on cytochrome p450 3a activity. Pharmacology 86, 287–292.
Madhavi, B. R., Mru, B. S., 2010. New RP-HPLC method for the analysis of montelukast sodium in pharmaceutical dosage forms. Interna J Chemtech Res 2(1), 471- 475.
Mendes, A., Desgranges, C., Chèze, C., Vercauteren, J., Freslon, J. L., 2003. Vasorelaxant effects of grape polyphenols in rat isolated aorta. Possible involvement of a purinergic pathway. Fundam Clinic Pharmacol 17(6), 673-681.
Merck & Co., INC., 2009. Singulair® (Montelukast sodium) Whitehouse Station, NJ 08889, USA. Merck canada INC. (2013). Product monograph: Singulair® montelukast (as montelukast sodium).
Miura, D., Miura, Y., Yagasaki, K., 2003., Hypolipidemic action of dietary resveratrol, a phytoalexin in grapes and red wine, in hepatoma -bearing rats. Life Science 73, 1393-1400.
Obolentseva, G. V., Litvinenko, V. I., Ammosov, A. S., Popova, T. P., Sampiev, A. M., 1999. Pharmacological and therapeutic properties of licorice preparations (a review). Pharmac Chem J 33(8), 427-434.
Papp, R., Luk, P., Mullett, W.M., Kwong, E., 2007. A rapid and sensitive method for the quantitation of montelukast in sheep plasma using liquid chromatography/tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci 858, 282–286. doi:10.1016/j.jchromb.2007.08.003
Rashmitha, N., Raj, T., Srinivas, C. H., Srinivas, N., Ray, U. K., Sharma, H. K., Mukkanti, K., 2010. A Validated RP-HPLC Method for theDetermination of Impurities in Montelukast Sodium. J Chem 7(2), 555-563.
Riccioni, G., Di Ilio, C., D’Orazio, N., 2004. An update of the leukotriene modulators for the treatment of asthma. Expert Opinion on Investigational Drugs 13(7), 763-77.
Saeed A. M., Sultana, N., Hussain, F., 2009. Spectrophotometric method for quantitative determination of montelukast in bulk, pharmaceutical formulations and human serum. J Analy Chem 64, 690–695. doi:10.1134/S1061934809070065
Shakalisava, Y., Regan, F., 2008. Determination of montelukast sodium by capillary electrophoresis. J Sep Sci 31, 1137–1143. doi:10.1002/jssc.200700591
Singh, R. R., Rathnam, M. V., 2012. A Stability indicating RPHPLC method for the estimation of Montelukast sodium and Fexofenadine hydrochloride in pharmaceutical preparations. Ind J Pharm Sci 4(2), 135-141.
Sripalakit, P., Kongthong, B., Saraphanchotiwitthaya, A., 2008. A simple bioanalytical assay for determination of montelukast in human plasma- application to a pharmacokinetic study. J Chromatogr B Analyt Technol Biomed Life Sci 869, 38–44. doi:10.1016/j.jchromb.2008.05.017
Tamir, S., Eizenberg, M., Somjen, D., Izrae, S., Vaya, J., 2001., Estrogen-like activity of glabrene and other constituents isolated from licorice root. J Stero Biochem Mol Biol 78(3), 291-298.
Yilmaz, Y., Toledo, R. T., 2004. Major flavonoids in grape seeds and skins: antioxidant capacity of catechin, epicatechin, and gallic acid. J of Agricult and Food Chemistr 52(2), 255-260.
Zhang, Y., Jayaprakasam, B., Seeram, N. P., Olson, L. K., DeWitt, D., Nair, M. G., 2004. Insulin secretion and cyclooxygenase enzyme inhibition by cabernet sauvignon grape skin compounds. J of Agricult and Food Chemistr 52(2), 228-233.
Zhou, D. Y., Du, Q., Li, R. R., Huang, M., Zhang, Q., Wei, G. Z. 2011., Grape seed proanthocyanidin extract attenuates airway inflammation and hyperresponsiveness in a murine model of asthma by down regulating inducible nitric oxide synthase. Planta medica 77(14), 1575-1581.
Published
2020-08-19
How to Cite
Hamad, M., Raad, R., Mallah, E., Zakaria , Z., Arafat , T., & Abu Dayyih, W. (2020). Development and Validation of Montelukast with Grape/Licorice Juices and its Application to Pharmacokinetic Studies by LC/MS. Indonesian Journal of Pharmacy, 31(3), 161-170. https://doi.org/10.22146/ijp.590
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Research Article
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