A HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY–MASS SPECTROMETRY/MASS SPECTROMETRY METHOD DEVELOPMENT FOR THE QUANTITATIVE DETERMINATION OF BISOPROLOL FROM CACO-2 CELL MONOLAYERS

Authors

  • Liliya Logoyda Department of Pharmaceutical Chemistry, Pharmaceutical Faculty, I.Horbachevsky Ternopil State Medical University, Ternopil, Ukraine
  • Dmytro Korobko Department of Pharmaceutical Chemistry, Pharmaceutical Faculty, I.Horbachevsky Ternopil State Medical University, Ternopil, Ukraine

DOI:

https://doi.org/10.22159/ajpcr.2018.v11i4.24990

Keywords:

Bisoprolol fumarate, Nil, recovery, Caco-2 cells, Bioavailability

Abstract

 Objective: A simple, rapid high-performance liquid chromatography–mass spectrometry (MS)/MS method was developed for the determination of bisoprolol from confluent Caco-2 monolayers and from aqueous solution.

Methods: Chromatography was achieved on discovery C 18, 50 mm×2.1 mm, 5 μm column. Samples were chromatographed in a gradient mode (eluent A [acetonitrile:water:formic acid, 5:95:0.1 v/v] and eluent B [acetonitrile:formic acid, 100:0.1 v/v]). The initial content of the eluent B is 0%, which increases linearly by 1.0 min to 100% and to 1.01 min returns to the initial 0%. The mobile phase was delivered at a flow rate of 0.400 ml/min into the mass spectrometer ESI chamber. The sample volume was 5 μl.

Results: Under these conditions, bisoprolol was eluted at 1.49 min. According to the Caco-2 test results, bisoprolol appeared to have moderate to high permeability. It should be noted that the recovery value for bisoprolol is 97.69%. Caco-2 permeability values for bisoprolol are in agreement with BCS Class I classification for these drugs and their known high bioavailability in humans.

Conclusion: From results of analysis, it can be concluded that developed method is simple and rapid for the determination of bisoprolol from confluent Caco-2 monolayers and from aqueous solution. Acquired results demonstrate that proposed strategy can be effortlessly and advantageously applied for the examination of bisoprolol from Caco-2 cell monolayers.

Downloads

Download data is not yet available.

References

Balimane PV, Han YH, Chong S. Current industrial practices of assessing permeability and P-glycoprotein interaction. AAPS J 2006;8:E1-13.

Braza AJ, Modamio P, Lastra CF, Mariño EL. Development, validation and analytical error function of two chromatographic methods with fluorimetric detection for the determination of bisoprolol and metoprolol in human plasma. Biomed Chromatogr 2002;16:517-22.

Agapova NN, Vasileva E. HPLC method for determination of bisoprolol and potential impurities. J Chromatogr A 1993;654:299-302.

Kintz P, Lohner S, Tracqui A, Mangin P, Lugnier A, Chaumont AJ. Rapid HPLC determination of bisoprolol in human plasma. J Anal Chem 1990;336:517-9.

Buehring KU, Garbe A. Determination of the new beta-blocker bisoprolol and of metoprolol, atenolol and propranolol in plasma and urine by high-performance liquid chromatography. J Chromatogr Biomed Appl 1986;55:215-24.

Arena A, Phillips J. Optimization of Caco-2 Cell Growth and Differentiation for Drug Transport Assay Studies Using a 96 well Multi Screen Caco-2 Assay System. Millipore Protocol Note PC1060EN00P; 2003.

Srinivasan B, Kolli AR, Esch MB, Abaci HE, Shuler ML, Hickman JJ, et al. TEER measurement techniques for in vitro barrier model systems. J Lab Autom 2015;20:107-26.

Logoyda L, Kondratova Y, Korobko D, Soroka Y. Development of UHPLC method for the determination of captopril in pharmaceutical dosage forms. Asian J Pharm Clin Res 2017;10:308-10.

Kondratova Y, Logoyda L, Voloshko Y, Abdel-Megied A, Korobko D, Soroka Y. Development and validation of HPLC-DAD method for the determination of bisoprolol in tablet dosage forms. Int J App Pharm 2017;9:54-9.

Logoyda L, Ahmed M. Abdel-Megied A, Kondratova Y, Trofimenko O, Korobko D, et al. Development and validation of HPLC method for the simultaneous determination of enalapril maleate in present of their impurities: Application to tablet analysis.Int J Appl Pharm 2018;10:98-102.

Fujikawa M, Ano R, Nakao K, Shimizu R, Akamatsu M. Relationships between structure and high-throughput screening permeability of diverse drugs with artificial membranes: Application to prediction of Caco-2 cell permeability. Bioorg Med Chem 2005;13:4721-32.

Gertz M, Harrison A, Houston JB, Galetin A. Prediction of human intestinal first-pass metabolism of 25 CYP3A substrates from in vitro clearance and permeability data. Drug Metab Dispos 2010;38:1147-58.

Yazdanian M, Briggs K, Jankovsky C, Hawi A. The high solubility†definition of the current FDA guidance on biopharmaceutical classification system may be too strict for acidic drugs. Pharm Res 2004;21:293-9.

Gozalbes R, Jacewicz M, Annand R, Tsaioun K, Pineda-Lucena A. QSAR-based permeability model for drug-like compounds. Bioorg Med Chem 2011;19:2615-24.

Hou TJ, Zhang W, Xia K, Qiao XB, Xu XJ. ADME evaluation in drug discovery 5. Correlation of caco-2 permeation with simple molecular properties. J Chem Inf Comput Sci 2004;44:1585-600.

Yee S. In vitro permeability across caco-2 cells (colonic) can predict in vivo (small intestinal) absorption in man – fact or myth. Pharm Res 1997;14:763-6.

Available from: http://www.cyprotex.com/admepk/in-vitro-permeability/caco-2-permeability.

Published

01-04-2018

How to Cite

Logoyda, L., and D. Korobko. “A HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY–MASS SPECTROMETRY/MASS SPECTROMETRY METHOD DEVELOPMENT FOR THE QUANTITATIVE DETERMINATION OF BISOPROLOL FROM CACO-2 CELL MONOLAYERS”. Asian Journal of Pharmaceutical and Clinical Research, vol. 11, no. 4, Apr. 2018, pp. 386-9, doi:10.22159/ajpcr.2018.v11i4.24990.

Issue

Section

Original Article(s)

Most read articles by the same author(s)