Development and validation of simple, rapid and sensitive LC-PDA ultraviolet method for quantification of Nebivolol in rat plasma and its application to pharmacokinetic studies

• Autorzy: Ravi P. , Vats R. , Joseph S. , Gadekar N.
• Języki publikacji: EN

Abstrakty

EN

A simple, sensitive and rapid high-performance liquid chromatography method with ultraviolet (UV) detector was developed and validated for the analysis of Nebivolol (NBL) in rat plasma. The plasma sample, spiked with raloxifene hydrochloride as an internal standard (IS), was subjected to single step protein precipitation method prior to analysis. Chromatographic separation was achieved on the Agilent C8 (150 mm × 4.6 mm, 5 μm) column and monitored at a wavelength of 280 nm. Elution was carried out, in an isocratic mode, using a mobile phase consisting of acetonitrile and potassium di-hydrogen orthophosphate buffer (pH 3.5 ± 0.1) in the ratio of 37:63 v/v. Retention times of IS and NBL were 5.1 ± 0.10 min and 8.01 ± 0.12 min, respectively. No interference was observed from plasma components in the analysis of NBL and IS. Calibration curve was linear over the range of 125–3000 ng/mL (r2 = 0.999). NBL was found to be stable under various processing and storage conditions. The developed method was applied in the quantification of NBL in plasma samples, determining various pharmacokinetic parameters from intravenous bolus and oral administration of the drug in Wistar rats. NBL was found to follow two compartmental open models in Wistar rats.

Słowa kluczowe

EN

liquid chromatography; nebivolol; internal standard; pharmacokinetic studies

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2015
• Tom: Vol. 27, no. 2
• Strony: 281--294
• Opis fizyczny: Bibliogr.25 poz., rys., tab.

Twórcy

autor

Ravi P.

• BITS-Pilani Hyderabad Campus Pharmacy Department Jawaharnagar, Ranga Reddy (Dist.) Andhra Pradesh India

autor

Vats R.

• BITS-Pilani Hyderabad Campus Pharmacy Department Jawaharnagar, Ranga Reddy (Dist.) Andhra Pradesh India

autor

Joseph S.

• BITS-Pilani Hyderabad Campus Pharmacy Department Jawaharnagar, Ranga Reddy (Dist.) Andhra Pradesh India

autor

Gadekar N.

• BITS-Pilani Hyderabad Campus Pharmacy Department Jawaharnagar, Ranga Reddy (Dist.) Andhra Pradesh India

Bibliografia

• [1] A. Van de Water, W. Janssens, J. Van Neuten, R. Xhonneux, J. De Cree, H. Verhaegen, R.S. Reneman, P.A. Jansse n, J. Cardiovasc. Pharmacol., 11, 552 (1988)
• [2] J.R. Cockcroft, P.J. Chowienczyk, S.E. Brett, C.P. Chen, A.G. Dupont, L. Van Nueten, S.J. Wooding, J.M. Ritter, J. Pharmacol. Exp. Therapeut., 274,1067 (1995)
• [3] D. Wojciechowski, V. Papademetriou, Expert Rev. Cardiovasc. Ther., 6, 471 (2008)
• [4] L. Van Nueten, J. De Crée Cardiovasc. Drugs Ther., 12, 339 (1998)
• [5] W. McNeely, K.L. Goa, Drugs, 57, 633 (1999)
• [6] M.A. Weber, Am. J. Hypertens., 18, 169S (2005)
• [7] T. Mizutani, Drug Metab. Rev., 35, 99 (2003)
• [8] W.E. Evans, M.V. Relling, A. Rahman, H.L. McLeod, E.P. Scott, J.S. Lin, J. Clin. Invest., 91,2150 (1993)
• [9] R. Weiss, Vasc Health Risk Manag., 2, 303 (2006)
• [10] B.S. Nayak, P. Ellaiah, D. Pattanayak, S. Das, Asian J. Pharmaceut., 5, 175 (2011)
• [11] S.S. Bushetti, P.M. Prashant, S. Kardame, RGUHS J. Pharmaceut. Sci., 1, 157 (2011)
• [12] F.M. Bertera, J.S. Del Mauro, A.H. Polizio, D. Chiappetta, C.A. Taira, C. Höcht, Naunyn-Schmiedeberg’s Arch. Pharmacol., 385, 833 (2012)
• [13] L. Ma, R. Gul, J. Habibi, M. Yang, L. Pulakat, A. Whaley-Connell, C.M. Ferrario, J.R. Sowers, Am. J. Physiol. Heart Circ. Physiol., 302, H2341 (2012)
• [14] G. Sacco, S. Evangelista, S. Manzini, M. Parlani, M. Bigioni, Fut. Cardiol., 7, 757 (2011)
• [15] D.A. Shah, K.K. Bhatt, R.S. Mehta, S.L. Baldania, T.R. Gandhi, Indian J. Pharm. Sci., 70, 591 (2008)
• [16] S.U. Kokil, M.S. Bhatia, Indian J. Pharm. Sci., 71, 111 (2009)
• [17] S.N. Meyyanathan, A.S. Birajdar, B. Suresh, Indian J. Pharm. Edu. Res., 44, 156 (2010)
• [18] L. Abdel-Fattah, L. Abdel-Aziz, A. El-Kosasy, M. Gaied, Drug Discov. Ther., 4, 418 (2010)
• [19] N.V. Ramakrishna, K.N. Vishwottam, M. Koteshwara, S. Manoj, M. Santosh, D.P. Varma, J. Pharm. Biomed.Anal., 39, 1006 (2005)
• [20] J. Nandania, S.J. Rajput, P. Contractor, P. Vasava, B. Solanki, M. Vohra, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 923-924, 110-119 (2013)
• [21] P.S. Selvan, K.V. Gowda, U. Mandal, W.D. Solomon, T.K. Pal, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 858, 143 (2007)
• [22] International Conference on Harmonization (ICH), Harmonized tripartite guideline on Topic Q2B, Notes for Guidelines for Validation of Analytical Procedures: Methodology; Pub. By: The Europe an Agency for the Evaluation of Medicinal Products, Human Medicines Evaluation Unit (1996)
• [23] Guidance for Industry: Bioanalytical metod validation. U.S. Department of Health and Human Services, Food and Drug Administration (2001)
• [24] D.V. McCalley, J. Chromatogr. A, 708, 185 (1995)
• [25] C. Stella, S. Rudaz, M. Mottaz, P.A. Carrupt, J.L. Veuthey, J. Sep. Sci., 27, 284 (2004)