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Current Analytical Chemistry

Editor-in-Chief

ISSN (Print): 1573-4110
ISSN (Online): 1875-6727

Research Article

Bioanalytical Method Development and Validation for the Determination of Vasopressin Receptor Antagonist Conivaptan in Mouse Plasma at NanoLevel and its Pharmacokinetic Application

Author(s): Haitham Alrabiah, Ahmed Bakheit, Sabray Attia and Gamal A.E. Mostafa*

Volume 15, Issue 5, 2019

Page: [591 - 598] Pages: 8

DOI: 10.2174/1573411014666180330160158

Price: $65

Abstract

Background: Conivaptan inhibits two of vasopressin receptor (vasopressin receptor V1a and V2). Conivaptan is used for the treatment of hyponatremia, and in some instances, for the treatment of the heart failure.

Methods: The present study aimed to develop a simple, sensitive, and accurate HPLC with ultraviolet detection for the assay of conivaptan (CON) in mouse plasma using bisoprolol as internal standard (IS). A precipitation procedure was used to extract CON and the IS from the mouse plasma. CON was chromatographically separated using a C18 analytical column at 25°C. The separation was carried out using a mixture of phosphate buffer (50 mM): acetonitrile (60: 40, v/v, pH 4.5) with a flow rate of 1.0 mL/min and detection was performed at 240 nm.

Results: The assay was validated according to the US Food and Drug (FDA) guidelines. The method demonstrated linearity over a concentration range of 150 - 2000 ng/mL (correlation coefficient: r 2 = 0.9985). The mean recovery of CON from the mouse plasma was 101.13%. All validation parameters for CON were within the acceptable range.

Conclusion: The investigated method has been shown to be suitable for estimating the CON in plasma samples, and this method is sensitive and highly selective, allowing the estimation of its concentrations up to the nano-scale. The suggested method was successfully used in a pharmacokinetic study of CON in mouse plasma.

Keywords: Conivaptan, vasopressin receptor, mouse plasma, HPLC, UV detection, pharmacokinetic.

Graphical Abstract
[1]
Palmer, B.F.; Rock, A.D.; Woodward, E.J. Dose comparison of conivaptan (Vaprisol®) in patients with euvolemic or hypervolemic hyponatremia–efficacy, safety, and pharmacokinetics. Drug design, Develop. Therap., 2016, 10, 339-351.
[2]
Koren, M.J.; Hamad, A.; Klasen, S.; Abeyratne, A.; McNutt, B.E.; Kalra, S. Efficacy and safety of 30-minute infusions of conivaptan in euvolemic and hypervolemic hyponatremia. Am. J. Health Syst. Pharm., 2011, 68(9), 818-827.
[3]
Verbalis, J.G.; Zeltser, D.; Smith, N.; Barve, A.; Andoh, M. Assessment of the efficacy and safety of intravenous conivaptan in patients with euvolaemic hyponatraemia: Subgroup analysis of a randomized, controlled study. Clin. Endocrinol. , 2008, 69(1), 159-168.
[4]
Velez, J.C.Q.; Dopson, S.J.; Sanders, D.S.; Delay, T.A.; Arthur, J.M. Intravenous conivaptan for the treatment of hyponatraemia caused by the syndrome of inappropriate secretion of antidiuretic hormone in hospitalized patients: A single-centre experience. Nephrol. Dial. Transplant., 2010, 25(5), 1524-1531.
[5]
Upadhyay, A.; Jaber, B.L.; Madias, N.E. Incidence and prevalence of hyponatremia. Am. J. Med., 2006, 119(7), S30-S35.
[6]
Sedlacek, M.; Schoolwerth, A.C.; Remillard, B.D. Critical care issues for the nephrologist: Electrolyte Disturbances in the Intensive Care Unit. In: Seminars in dialysis; Wiley Online Library, 2006, pp. 496-501.
[7]
Goldsmith, S.R.; Elkayam, U.; Haught, W.H.; Barve, A.; He, W. Efficacy and safety of the vasopressin V1A/V2-receptor antagonist conivaptan in acute decompensated heart failure: A dose-ranging pilot study. J. Card. Fail., 2008, 14(8), 641-647.
[8]
Zeynalov, E.; Jones, S.M.; Seo, J.W.; Snell, L.D.; Elliott, J.P. Arginine-vasopressin receptor blocker conivaptan reduces brain edema and blood-brain barrier disruption after experimental stroke in mice. PLoS One, 2015, 10(8)e0136121
[9]
Rajan, S.; Soumya, S.; Jerry, P.; Lakshmi, K. Effectiveness of single dose conivaptan for correction of hyponatraemia in post-operative patients following major head and neck surgeries. Indian J. Anaesth., 2015, 59(7), 416-420.
[10]
Udelson, J.E.; Smith, W.B.; Hendrix, G.H.; Painchaud, C.A.; Ghazzi, M.; Thomas, I.; Ghali, J.K.; Selaru, P.; Chanoine, F.; Pressler, M.L.; Konstam, M.A. Acute hemodynamic effects of conivaptan, a dual V1A and V2 vasopressin receptor antagonist, in patients with advanced heart failure. Circulation, 2001, 104(20), 2417-2423.
[11]
Sahu, R.; Balaguru, D.; Thapar, V.; Haque, I.; Pham-Peyton, C.; Bricker, J.T. Conivaptan therapy in an infant with severe hyponatremia and congestive heart failure. Tex. Heart Inst. J., 2012, 39(5), 724-726.
[12]
Hoque, M.Z.; Pradeep, A.; Nazmul, H.; Nitin, V.; Mitul, A.; Darshak, H.K. Conivaptan: Promise of treatment in heart failure. Expert Opin. Pharmacother., 2009, 10(13), 2161-2169.
[13]
Hubert, P.; Nguyen-Huu, J.J.; Boulanger, B.; Chapuzet, E.; Chiap, P.; Cohen, N.; Compagnon, P.A.; Dewé, W.; Feinberg, M.; Lallier, M.; Laurentie, M. Harmonization of strategies for the validation of quantitative analytical procedures: A SFSTP proposal–part II. J. Pharm. Biomed. Anal., 2007, 45(1), 70-81.
[14]
Sennbro, C.J.; Knutsson, M.; Timmerman, P.; Van Amsterdam, P. Anticoagulant counter ion impact on bioanalytical LC–MS/MS assay performance: Additional validation required? Bioanalysis, 2001, 3(21), 2389-2391.
[15]
González, O.; Blanco, M.E.; Iriarte, G.; Bartolomé, L.; Maguregui, M.I.; Alonso, R.M. Bioanalytical chromatographic method validation according to current regulations, with a special focus on the non-well defined parameters limit of quantification, robustness and matrix effect. J. Chromatogr. A, 2014, 1353, 10-27.
[16]
FDA guidance for industry: Bioanalytical method validation; US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research: Rockville, MD, 2001.
[17]
Khady, A.A.; AlRabiah, H.; Attwa, M.W.; Sabray, A.; Mostafa, G.A.E. Development and validation of HPLC‐MS/MS method for the determination of lixivaptan in mouse plasma and its application in a pharmacokinetic study. Biomed. Chromatogr., 2017, 31(11)e4007
[18]
Lei, M.; Gan, W.; Sun, Y. HPLC-MS/MS analysis of peramivir in rat plasma: Elimination of matrix effect using the phospholipid‐removal solid‐phase extraction method. Biomed. Chromatogr., 2018, 32(3)
[http://dx.doi.org/10.1002/bmc.4103]
[19]
Miller, J.N.; Miller, J.C. Statistics and chemometrics for analytical chemistry, 6th ed; Pearson Education: London, 2005.
[20]
Guideline, ICH Validation of analytical procedures: text and methodology. Q2 (R1) 2005, 1
[21]
Shabir, G.A. Validation of high-performance liquid chromatography methods for pharmaceutical analysis: Understanding the differences and similarities between validation requirements of the US Food and Drug Administration, the US Pharmacopeia and the International Conference on Harmonization. J. Chromatogr. A, 2003, 987(1), 57-66.
[22]
Mao, Z.L.; Stalker, D.; Keirns, J. Pharmacokinetics of conivaptan hydrochloride, a vasopressin V1A/V2-receptor antagonist, in patients with euvolemic or hypervolemic hyponatremia and with or without congestive heart failure from a prospective, 4-day open-label study. Clin. Therapeut., 2009, 31(7), 1542-1550.

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