High-performance liquid chromatographic determination of montelukast sodium in human plasma: Application to bioequivalence study

• Autorzy: Shakya A. , Arafat T. , Hakooz N. M. , Abuawwad A. N. , Al-Hroub H. , Melhim M.
• Języki publikacji: EN

Abstrakty

EN

A simple, sensitive, and precise high-performance liquid chromatographic (HPLC) method for quantitation of montelukast in human plasma has been developed and validated. Commercially available candesartan cilexetil was used as an internal standard. After protein precipitation, montelukast and candesartan cilexetil (I.S.) in human plasma were analyzed using mobile phase containing 62% v/v acetonitrile and 38% v/v buffer (containing 1 mL L^-1 triethylamine as peak modifier, final pH adjusted to 2.5 with orthophosphoric acid). Chromatographic separation was achieved on a BDS Hypersil-C18 column (50 × 4.6 mm i.d., particle size 5 μm; Thermo Electron Corporation, USA) using isocratic elution at a flow rate of 1.5 mL min−1. The signals were monitored using a fluorescence detector set at 350 nm for excitation and 400 nm for emission. The total time for a chromatographic separation was ∼3 min. The validated quantitation ranges of this method were 5–300 ng mL^-1 with coefficients of variation between 1.75% and 9.38%. Mean recoveries were 91.8 ± 3.8%. The within- and between-batch precisions were 0.74–2.46% and 1.64–7.87%, respectively. The within- and between-batch relative errors (bias) were 0.14–3.3% and 0.08–4.6%, respectively. Stability of montelukast in plasma was >94.7%, with no evidence of degradation during sample processing and 30 days storage in a deep freezer at −70°C. This validated method is sensitive and simple with between-batch precision of <8% and successfully applied for the bioequivalence studies. The formulations were compared using the following pharmacokinetic parameters: AUC0−t, AUC0−∞, and Cmax. No statistically significant difference (p > 0.05) was observed between the logarithmically transformed AUC0−t, AUC0−∞, and Cmax values.

Słowa kluczowe

EN

montelukast; assay; HPLC; plasma; fluorescence; bioequivalence application

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2014
• Tom: Vol. 26, no. 3
• Strony: 457--472
• Opis fizyczny: Bibliogr. 25 poz., rys., tab.

Twórcy

autor

Shakya A.

• Al-Ahliyya Amman University Faculty of Pharmacy and Medical Sciences PO Box 263 Amman 19328 Jordan

autor

Arafat T.

• Petra University Faculty of Pharmacy PO Box 961343 Amman Jordan

autor

Hakooz N. M.

• Zarqa University Faculty of Pharmacy Zarqa 13132 Jordan

autor

Abuawwad A. N.

• Jordan Center for Pharmaceutical Research PO Box 950435 Amman 11495 Jordan

autor

Al-Hroub H.

• Jordan Center for Pharmaceutical Research PO Box 950435 Amman 11495 Jordan

autor

Melhim M.

• Jordan Center for Pharmaceutical Research PO Box 950435 Amman 11495 Jordan

Bibliografia

• [1] M. Labelle, M. Belley, Y. Gareau, J.Y. Gauthier, D. Guay, R. Gordon, S.G. Grossman, T.R. Jones, Y. Leblanc, M. McAuliffe, C.S. McFarlane, P. Masson, K.M. Metters, N. Ouimet, D.H. Patrick, H. Piechuta, C. Rochette, N. Sawyer, Y.B. Xiang, C.B. Pickett, A.W. Ford-Hutchinson, R.J. Zamboni, and R.N. Young, Bioorg. Med. Chem. Lett., 5, 283 (1995).
• [2] T.R. Jones, M. Labelle, M. Belley, E. Champion, L. Charette, J. Evans, A.W. Ford- Hutchinson, J.Y. Gauthier, A. Lord, P. Masson, M. McAuliffe, C.S. McFarlane, K.M. Metters, C. Pickett, H. Piechuta, C. Rochette, I.W. Rodger, N. Sawyer, R.N. Young, R. Zamboni, and W.M. Abraham, Can. J. Physiol. Pharmacol., 73, 191 (1995).
• [3] B. Knorr, J. Matz, J.A. Bernstein, H. Nguyen, B.C. Seidenberg, T.F. Reiss, and A. Becker, JAMA, 279, 1181 (1998).
• [4] L.A. Stohlmeyer, J. Pediatr. Health Care, 12, 324 (1998).
• [5] K. Malmstrom, G. Rodriguez-Gomez, J. Guerra, C. Villaran, A. Pineiro, L. Wei, B. Scidenberg, and T. Reiss, Ann. Intern. Med., 130, 487(1997).
• [6] B. Knorr, S. Holland, J.D. Rogers, H.H. Nguyen, and T.F. Reiss, J. Allergy Clin. Immunol., 106, 171 (2000).
• [7] H. Bisgaard, Pediatrics, 107, 381 (2001).
• [8] Singulair® (Montelukast sodium) Tablets, Chewable Tablets and Oral Granules (Product Information), Merck & Co., Inc., New Jersey, 2012. http://www.merckfrosst.ca/assets/en/pdf/products/SINGULAIR-PM_E.pdf
• [9] H.T. Kim, Y.K. Song, S.D. Lee, Y. Park, and C.K. Kim, Arzneimittelforschung, 62, 123 (2012).
• [10] H. Cheng, J.A. Leff, R. Amin, B.J. Gertz, M. De Smet, N. Noonan, J.D. Rogers, W. Malbecq, D. Meisner, and G. Somers, Pharm. Res., 13, 445 (1996).
• [11] R. Papp, P. Luk, W.M. Mullett, and E. Kwong, J. Chromatogr., B: Anal. Technol. Biomed. Life Sci., 858, 282 (2007).
• [12] S.K. Balani, X. Xu, V. Pratha, M.A. Koss, R.D. Amin, C. Dufresne, R.R. Miller, B.H. Arison, G.A. Doss, M. Chiba, A. Freeman, S.D. Holland, J.I. Schwartz, K.C. Lasseter, B.J. Gertz, J.I. Isenberg, J.D. Rogersm, J.H. Lin, and T.A. Baillie, Drugs Metab. Dispos., 25, 1282 (1997).
• [13] R.T. Sane, A. Menzes, M. Mote, A. Moghe, and G. Gandi, J. Planar Chromatogr., 17, 75 (2004).
• [14] I. Alsarra, M. Al-Qmar, E.A. Gadkariem, and F. Belal, Il Farmaco, 60, 563 (2005).
• [15] R.D. Amin, H. Cheng and J.D. Rogers, J. Pharm. Biomed. Anal., 13, 155 (1995).
• [16] L. Liu, H. Cheng, J.J. Zhao and J.D. Rogers, J. Pharm. Biomed. Anal., 15, 631 (1997).
• [17] H. Ochiai, N. Uchiyama, T. Takano, K. Hara and T. Kamei, J. Chromatogr., B, 713, 409 (1998).
• [18] S. Al-Rawithi, S. Al-Gazlan, W. Al-Ahmadi, I.A. Alshowaier, A. Yusuf and D.A. Raines, J. Chromatogr., B, 754, 527 (2001).
• [19] C.J. Kichen, A.Q. Wang, D.G. Musson, A.Y. Yang and A.L. Fisher, J. Pharm. Biomed. Anal., 31, 647 (2003).
• [20] G.A. Smith, C.M. Rawls and R.L. Kunka, Pharm. Res., 21, 1539 (2004).
• [21] P. Sripalakit, B. Kongthong, and A. Saraphanchotiwitthaya, J. Chromatogr., B: Anal. Technol. Biomed. Life Sci., 869, 38 (2008).
• [22] G.R. Graff, A. Webber, D. Wessler-Starman, and A.L. Smith, J. Pediatr., 142, 53, (2003).
• [23] A. Shafaati, A. Zarghi, S.M. Foroutan, A. Khoddam, and B. Madadian, J. Bioequivalence Bioavailability, 2, 135 (2010).
• [24] US Department of Health and Human Services, Food and Drug Administration, Guidance for Industry: Bioanalytical Method Validation, Centre for Drug Evaluation and Research (CDER), Rockville, MD, 2001, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070107.pdf
• [25] US Department of Health and Human Services, Food and Drug Administration, Guidance for Industry: Bioavailability and Fed Bioequivalence Studies for Orally Administered Drug Product-General Considerations. Centre for Drug Evaluation and Research (CDER), Rockville, MD, 2003.