Research Article

A newly developed and fully validated HPLC method for simultenous determination of in-situ single pass intestinal permeability of domperidone, metoprolol tartarate and phenol red

Volume: 27 Number: 3 June 28, 2025

A newly developed and fully validated HPLC method for simultenous determination of in-situ single pass intestinal permeability of domperidone, metoprolol tartarate and phenol red

Abstract

One of the most popular methods for figuring out a drug’s intestinal permeability is the intestinal perfusion (SPIP) approach. Metoprolol as tartrate and phenol red are frequently utilized as reference compounds in perfusion tests to assess the permeability coefficient of the study’s focus component, Domperidone maleate. Our study’s goal was to create and validate a reversed-phase liquid chromatographic technique for the simultaneous detection of Domperidone maleate, metoprolol, and phenol red for use in intestinal perfusion studies. The analysis was performed on a C18 column 150 × 1.5 mm, 5.0 μm using a mobile phase consisting of methanol: 20 mM potassium dihydrogen phosphate buffer 43:57, v/v; pH 3.1. The procedure was validated using the FDA’s standards for stability, linearity, precision, and accuracy. All calibration curves were linear r2> 0.99. The system suitability parameters of the method are the required limits all analytes. The in situ intestinal permeability experiments can easily be standardized with the help of this newly created and proven approach.

Keywords

References

  1. [1.] Dahan A, Miller JM, Amidon GL. Prediction of solubility and permeability class membership: provisional BCS classification of the world's top oral drugs. AAPS J. 2009;11(4):740-6. http://dx.doi.org/10.1208/s12248-009-9144-x.
  2. [2.] Lennernas H. Intestinal permeability and its relevance for absorption and elimination. Xenobiotica. 2007;37(10-11):1015-51. http://dx.doi.org/10.1080/00498250701704819.
  3. [3.] Lozoya-Agullo I, Zur M, Wolk O, Beig A, Gonzalez-Alvarez I, Gonzalez-Alvarez M, et al. In-situ intestinal rat perfusions for human Fabs prediction and BCS permeability class determination: Investigation of the single-pass vs. the Doluisio experimental approaches. Int J Pharm. 2015;480(1-2):1-7. http://dx.doi.org/10.1016/j.ijpharm.2015.01.014.
  4. [4.] Doluisio JT, Tan GH, Billups NF, Diamond L. Drug absorption. II. Effect of fasting on intestinal drug absorption. J Pharm Sci. 1969;58(10):1200-2. http://dx.doi.org/10.1002/jps.2600581007.
  5. [5.] Amidon GL, Sinko PJ, Fleisher D. Estimating human oral fraction dose absorbed: a correlation using rat intestinal membrane permeability for passive and carrier-mediated compounds. Pharm Res. 1988;5(10):651-4. http://dx.doi.org/10.1023/a:1015927004752.
  6. [6.] Lozoya-Agullo I, Gonzalez-Alvarez I, Zur M, Fine-Shamir N, Cohen Y, Markovic M, et al. Closed-Loop Doluisio (Colon, Small Intestine) and Single-Pass Intestinal Perfusion (Colon, Jejunum) in Rat-Biophysical Model and Predictions Based on Caco-2. Pharm. Res. 2018;35(1):1-23. http://dx.doi.org/10.1007/s11095-017-2331-z.
  7. [7.] Reddymasu SC, Soykan I, McCallum RW. Domperidone: review of pharmacology and clinical applications in gastroenterology. Am J Gastroenterol. 2007;102(9):2036-45. http://dx.doi.org/10.1111/j.1572-0241.2007.01255.x.
  8. [8.] Breuil L, Goutal S, Marie S, Del Vecchio A, Audisio D, Soyer A, et al. Comparison of the Blood-Brain Barrier Transport and Vulnerability to P-Glycoprotein-Mediated Drug-Drug Interaction of Domperidone versus Metoclopramide Assessed Using In Vitro Assay and PET Imaging. Pharmaceutics. 2022;14(8):1658. http://dx.doi.org/10.3390/pharmaceutics14081658.

Details

Primary Language

English

Subjects

Pharmaceutical Analytical Chemistry

Journal Section

Research Article

Publication Date

June 28, 2025

Submission Date

November 2, 2022

Acceptance Date

January 10, 2023

Published in Issue

Year 2023 Volume: 27 Number: 3

APA
Özcan, S., Çağlar, E. Ş., Kaynak, M. S., & Üstündağ, N. (2025). A newly developed and fully validated HPLC method for simultenous determination of in-situ single pass intestinal permeability of domperidone, metoprolol tartarate and phenol red. Journal of Research in Pharmacy, 27(3), 967-979. https://izlik.org/JA27AP76EL
AMA
1.Özcan S, Çağlar EŞ, Kaynak MS, Üstündağ N. A newly developed and fully validated HPLC method for simultenous determination of in-situ single pass intestinal permeability of domperidone, metoprolol tartarate and phenol red. J. Res. Pharm. 2025;27(3):967-979. https://izlik.org/JA27AP76EL
Chicago
Özcan, Saniye, Emre Şefik Çağlar, Mustafa Sinan Kaynak, and Neslihan Üstündağ. 2025. “A Newly Developed and Fully Validated HPLC Method for Simultenous Determination of In-Situ Single Pass Intestinal Permeability of Domperidone, Metoprolol Tartarate and Phenol Red”. Journal of Research in Pharmacy 27 (3): 967-79. https://izlik.org/JA27AP76EL.
EndNote
Özcan S, Çağlar EŞ, Kaynak MS, Üstündağ N (June 1, 2025) A newly developed and fully validated HPLC method for simultenous determination of in-situ single pass intestinal permeability of domperidone, metoprolol tartarate and phenol red. Journal of Research in Pharmacy 27 3 967–979.
IEEE
[1]S. Özcan, E. Ş. Çağlar, M. S. Kaynak, and N. Üstündağ, “A newly developed and fully validated HPLC method for simultenous determination of in-situ single pass intestinal permeability of domperidone, metoprolol tartarate and phenol red”, J. Res. Pharm., vol. 27, no. 3, pp. 967–979, June 2025, [Online]. Available: https://izlik.org/JA27AP76EL
ISNAD
Özcan, Saniye - Çağlar, Emre Şefik - Kaynak, Mustafa Sinan - Üstündağ, Neslihan. “A Newly Developed and Fully Validated HPLC Method for Simultenous Determination of In-Situ Single Pass Intestinal Permeability of Domperidone, Metoprolol Tartarate and Phenol Red”. Journal of Research in Pharmacy 27/3 (June 1, 2025): 967-979. https://izlik.org/JA27AP76EL.
JAMA
1.Özcan S, Çağlar EŞ, Kaynak MS, Üstündağ N. A newly developed and fully validated HPLC method for simultenous determination of in-situ single pass intestinal permeability of domperidone, metoprolol tartarate and phenol red. J. Res. Pharm. 2025;27:967–979.
MLA
Özcan, Saniye, et al. “A Newly Developed and Fully Validated HPLC Method for Simultenous Determination of In-Situ Single Pass Intestinal Permeability of Domperidone, Metoprolol Tartarate and Phenol Red”. Journal of Research in Pharmacy, vol. 27, no. 3, June 2025, pp. 967-79, https://izlik.org/JA27AP76EL.
Vancouver
1.Saniye Özcan, Emre Şefik Çağlar, Mustafa Sinan Kaynak, Neslihan Üstündağ. A newly developed and fully validated HPLC method for simultenous determination of in-situ single pass intestinal permeability of domperidone, metoprolol tartarate and phenol red. J. Res. Pharm. [Internet]. 2025 Jun. 1;27(3):967-79. Available from: https://izlik.org/JA27AP76EL