A Review of HPLC and UPLC Methods for Quantify- ing Domperidone in Plasma and Serum Matrices in Pharmacokinetic Research
DOI:
https://doi.org/10.60988/p.v37i4.105Keywords:
Domperidone, HPLC, UPLC, Pharmacokinetics study, biological matricesAbstract
Domperidone is recently being modified into various better formulations to improve its bioavailability. Meanwhile, the usage of domperidone together with the specific drug may cause the interaction between the drugs. Therefore, a pharmacokinetic study is needed to provide bioequivalence data for the new formula and clinical interaction evidence. Plasma or serum is commonly used as a biological sample in pharmacokinetic evaluation. It is critical to have a simple, sensitive, and valid method for determining domperidone in biological matrices. Liquid chromatography offers excellent performance in quantifying the drug in plasma. This review describes the application of high-performance liquid chromatography (HPLC) and ultra-performance liquid chromatography (UPLC) coupled with different detectors to quantify domperidone in plasma or serum matrices. Several extraction methods of sample preparation are also highlighted.
References
British Pharmacopoeia Comission (2009) British Pharmacopoeia, London.
Patil, H.G., R.V. Tiwari, M.A. Repka, and K.K. Singh. Formulation and development of orodispersible sustained release tablet of domperidone. Drug. Dev. Ind. Pharm. 42. 906–915, 2016.
Fernandes, D.C.R., and A.J. Norman. Drug-induced gastrointestinal disorders. Medicine. 47. 301–308, 2019.
Wang, Y., S. Chen, and L. Wu. Systematic review of domperidone in clinical practice. Chinese J Gastroenterol. 16. 226–230, 2011.
Singh, P., S.S. Yoon, and B. Kuo. Nausea: a review of pathophysiology and therapeutics. Therap Adv Gastroenterol. 9. 98–112, 2016.
Schey, R., M. Saadi, D. Midani, A.C. Roberts, R. Parupalli, and H.P. Parkman. Domperidone to Treat Symptoms of Gastroparesis: Benefits and Side Effects from a Large Single-Center Cohort. Dig Dis Sci. 61. 3545–3551, 2016.
Reddymasu, S.C., I. Soykan, and R.W. McCallum. Domperidone: Review of pharmacology and clinical applications in gastroenterology. Am J Gastroenterol. 102. 2036–2045, 2007.
Palem, C.R., R. Gannu, N. Doodipala, V.V. Yamsani, and M.R. Yamsani. Transmucosal delivery of domperidone from bilayered buccal patches: In Vitro, Ex Vivo and In Vivo characterization. Arch. Pharm. Res. 34. 1701–1710, 2011.
Athukuri, B.L., and P. Neerati. Enhanced oral bioavailability of domperidone with piperine in male wistar rats: Involvement of CYP3A1 and P-gp inhibition. J. Pharm. Pharm. Sci. 20. 28–37, 2017.
Zayed, G.M., S.A.-E. Rasoul, M.A. Ibrahim, M.S. Saddik, and D.H. Alshora. In vitro and in vivo characterization of domperidone-loaded fast dissolving buccal films. Saudi Pharm. J. 28. 266–273, 2020.
Templeton, I., P. Ravenstijn, C. Sensenhauser, and J. Snoeys. A physiologically based pharmacokinetic modeling approach to predict drug-drug interactions between domperidone and inhibitors of CYP3A4: PK modelling of DDI domperidone and inhibitors of CYP3A4. Biopharm Drug Dispos. 37. 15–27, 2016.
Ortiz, A., C.J. Cooper, Y. Gomez, I. Sarosiek, R.W. McCallum, and A. Alvarez. Cardiovascular Safety Profile and Clinical Experience With High-Dose Domperidone Therapy for Nausea and Vomiting. Am. J. Med. Sci. 349. 421–424, 2015.
Akhter, S., G.K. Jain, F.J. Ahmad, R.K. Khar, N. Jain, Z.I. Khan, and S. Talegaonkar. Investigation of Nanoemulsion System for Transdermal Delivery of Domperidone : Ex-vivo and in vivo Studies. Curr. Nanosci. 4. 381–390, 2008.
Charoenying, T., P. Patrojanasophon, T. Ngawhirunpat, T. Rojanarata, P. Akkaramongkolporn, and P. Opanasopit. Three-dimensional (3D)-printed devices composed of hydrophilic cap and hydrophobic body for improving buoyancy and gastric retention of domperidone tablets. Eur. J. Pharm. Sci. 155. 105555, 2020.
Zafar, A., M. Afzal, A.M. Quazi, M. Yasir, I. Kazmi, F.A. Al-Abaasi, N.K. Alruwaili, K.S. Alharbi, S.I. Alzarea, S. Sharma, and R. Kaur. Chitosan-ethyl cellulose microspheres of domperidone for nasal delivery: preparation, in-vitro characterization, in-vivo study for pharmacokinetic evaluation and bioavailability enhancement. J. Drug Deliv. Sci. Technol. 102471, 2021.
Tetyczka, C., M. Griesbacher, M. Absenger-Novak, E. Fröhlich, and E. Roblegg. Development of nanostructured lipid carriers for intraoral delivery of Domperidone. International Journal of Pharmaceutics. 526. 188–198, 2017.
Al-lami, M.S., M.H. Oudah, and F.A. Rahi. Preparation and characterization of domperidone nanoparticles for dissolution improvement. Iraqi Journal of Pharmaceutical Sciences ( P-ISSN: 1683 - 3597 , E-ISSN : 2521 - 3512). 27. 39–52, 2018.
Daihom, B.A., E.R. Bendas, M.I. Mohamed, and A.A. Badawi. Development and in vitro evaluation of domperidone/Dowex resinate embedded gastro-floatable emulgel and effervescent alginate beads. Journal of Drug Delivery Science and Technology. 59. 101941, 2020.
Alhumayyd, M., I. Bukhari, and A. Almotrefi. PP211—Piperine Increases Plasma Domperidone Concentrations in the Rat. Clin. Ther. 35. e84, 2013.
Boyce, M.J., K.J. Baisley, and S.J. Warrington. Pharmacokinetic interaction between domperidone and ketoconazole leads to QT prolongation in healthy volunteers: a randomized, placebo-controlled, double-blind, crossover study: QT study of domperidone and ketoconazole. Br. J. Clin. Pharmacol. 73. 411–421, 2012.
Yoshizato, T., K. Tsutsumi, T. Kotegawa, H. Imai, and S. Nakano. Determination of domperidone in human plasma using high performance liquid chromatography with fluorescence detection for clinical application. J. Chromatogr. B. 961. 86–90, 2014.
Mohamed, M.K., J. Takyi-Williams, B. Baudot, and A. Grobler. Development and validation of a LC-HRMS method for the quantification of cannabinoids and their metabolites in human plasma. Eur. J. Pharm. Sci. 159. 105705, 2021.
Tikhomirov, M., B. Poźniak, and T. Śniegocki. High-Performance Liquid Chromatography-Tandem Mass Spectrometry for Buprenorphine Evaluation in Plasma—Application to Pharmacokinetic Studies in Rabbits. Molecules. 26. 437, 2021.
Nazario, C.E.D., B.H. Fumes, M.R. da Silva, and F.M. Lanças. New materials for sample preparation techniques in bioanalysis. Journal of Chromatography B. 1043. 81–95, 2017.
Lakshmana, S., and T.N.K. Suriyaprakash. Extraction of Drug from the Biological Matrix: A Review. Applied Biological Engineering - Principles and Practice, 2012.
Bovo, S., G. Schiavo, G. Galimberti, F. Fanelli, F. Bertolini, S. Dall’Olio, U. Pagotto, and L. Fontanesi. Comparative targeted metabolomic profiles of porcine plasma and serum. Animal. 17, 2023.
Satyavert, S. Gupta, A.B. Nair, and M. Attimarad. Development and validation of bioanalytical method for the determination of hydrazinocurcumin in rat plasma and organs by HPLC-UV. Journal of Chromatography B. 1156. 122310, 2020.
Domingues, D.S., M.A.L. Pinto, I.D. de Souza, J.E.C. Hallak, J.A. de S. Crippa, and M.E.C. Queiroz. Determination of Drugs in Plasma Samples by High-Performance Liquid Chromatography–Tandem Mass Spectrometry for Therapeutic Drug Monitoring of Schizophrenic Patients. Journal of Analytical Toxicology. 40. 28–36, 2016.
Cruz, J.C., I.D. de Souza, C.F. Grecco, E.C. Figueiredo, and M.E.C. Queiroz. Recent advances in column switching high-performance liquid chromatography for bioanalysis. Sustainable Chemistry and Pharmacy. 21. 100431, 2021.
Kohler, I., J. Schappler, and S. Rudaz. Microextraction techniques combined with capillary electrophoresis in bioanalysis. Anal Bioanal Chem. 405. 125–141, 2013.
Sichilongo, K., E. Mwando, E. Sepako, and A. Massele. Comparison of efficiencies of selected sample extraction techniques for the analysis of selected antiretroviral drugs in human plasma using LC-MS. J Pharmacol Toxicol Methods. 89. 1–8, 2018.
Stokvis, E., H. Rosing, and J.H. Beijnen. Liquid chromatography-mass spectrometry for the quantitative bioanalysis of anticancer drugs. Mass Spectrom. Rev. 24. 887–917, 2005.
Flanagan, R.J., P.E. Morgan, E.P. Spencer, and R. Whelpton. Micro-extraction techniques in analytical toxicology: short review. Biomed. Chromatogr. 20. 530–538, 2006.
Niu, Z., W. Zhang, C. Yu, J. Zhang, and Y. Wen. Recent advances in biological sample preparation methods coupled with chromatography, spectrometry and electrochemistry analysis techniques. Trends Analyt Chem. 102. 123–146, 2018.
Yang, S., L. Mu, R. Feng, and X. Kong. Selection of Internal Standards for Quantitative Matrix-Assisted Laser Desorption/Ionization Mass Spectrometric Analysis Based on Correlation Coefficients. ACS Omega. 4. 8249–8254, 2019.
Zenkevich, I.G., E.D. Makarov, and I.Y. Makarova. Quantitative chromatographic analysis under changes in the composition of samples in the course of sample preparation: A modification of the double internal standard method. J Anal Chem. 62. 748–755, 2007.
Wang, M., C. Wang, and X. Han. Selection of internal standards for accurate quantification of complex lipid species in biological extracts by electrospray ionization mass spectrometry-What, how and why? Mass Spec Rev. 36. 693–714, 2017.
Jeanne Dit Fouque, D., A. Maroto, and A. Memboeuf. Internal Standard Quantification Using Tandem Mass Spectrometry of a Tryptic Peptide in the Presence of an Isobaric Interference. Anal. Chem. 90. 14126–14130, 2018.
Sabourian, R., S.Z. Mirjalili, N. Namini, F. Chavoshy, M. Hajimahmoodi, and M. Safavi. HPLC methods for quantifying anticancer drugs in human samples: A systematic review. Anal. Biochem. 610. 113891, 2020.
Veigure, R., K. Lossmann, M. Hecht, E. Parman, R. Born, I. Leito, K. Herodes, and K. Kipper. Retention of acidic and basic analytes in reversed phase column using fluorinated and novel eluent additives for liquid chromatography-tandem mass spectrometry. J. Chromatogr. A. 1613. 460667, 2020.
Rosés, M. Determination of the pH of binary mobile phases for reversed-phase liquid chromatography. J. Chromatogr. A. 1037. 283–298, 2004.
Heinisch, S., and J. Rocca. Effect of mobile phase composition, pH and buffer type on the retention of ionizable compounds in reversed-phase liquid chromatography: application to method development. J. Chromatogr. A. 1048. 183–193, 2004.
National Center for Biotechnology Information. PubChem Compound Summary for CID 5255699, 2021.
Martino, R., M. Malet-Martino, V. Gilard, and S. Balayssac. Counterfeit drugs: analytical techniques for their identification. Anal Bioanal Chem. 398. 77–92, 2010.
Siddiqui, M.R., Z.A. AlOthman, and N. Rahman. Analytical techniques in pharmaceutical analysis: A review. Arab. J. Chem. 10. S1409–S1421, 2017.
Pitt, J.J. Principles and Applications of Liquid Chromatography-Mass Spectrometry in Clinical Biochemistry. Clin Biochem Rev. 30. 19–34, 2009.
Ali, I., V.K. Gupta, P. Singh, and U. Negi. SPE-HPLC techniques for separation and identification of domperidone in human plasma. .J. Liq. Chromatogr. Relat. Technol. 37. 2587–2597, 2014.
Pawestri, S.A. Formulasi Matriks Patch Transdermal Domperidone serta Uji In Vitro dan In Vivo, 2021.
Pawestri, S.A., A.K. Nugroho, E. Lukitaningsih, and P. Purwantiningsih. Validation and Quantification of Domperidone in Spiked Plasma Matrix Using Reversed Phase HPLC-UV Method. Indonesian Journal of Chemistry. 21. 1180–1186, 2021.
Salehi, S., S. Rasoul-Amini, N. Adib, and M. Shekarchi. Synthesis of molecular imprinted polymers for selective extraction of domperidone from human serum using high performance liquid chromatography with fluorescence detection. J. Chromatogr. B. 1027. 165–173, 2016.
Li, Z., J. Yao, Z. Zhang, and L. Zhang. Simultaneous Determination of Omeprazole and Domperidone in Dog Plasma by LC-MS Method. J. Chromatogr. Sci. 47. 883–884, 2009.
Khan, A., Z. Iqbal, I. Khadra, L. Ahmad, A. Khan, M.I. Khan, Z. Ullah, and Ismail. Simultaneous determination of domperidone and Itopride in pharmaceuticals and human plasma using RP-HPLC/UV detection: Method development, validation and application of the method in in-vivo evaluation of fast dispersible tablets. J. Pharm. Biomed. Anal. 121. 6–12, 2016.
Vij, M., N. Dand, L. Kumar, A. Ankalgi, P. Wadhwa, S. Alshehri, F. Shakeel, M.M. Ghoneim, P. Alam, and S.U.D. Wani. RP-HPLC-Based Bioanalytical Approach for Simultaneous Quantitation of Cinnarizine and Domperidone in Rat Plasma. Separations. 10. 159, 2023.
Sher, N., F.A. Siddiqui, N. Hasan, N. Shafi, A. Zubair, and A.Z. Mirza. Simultaneous determination of antihistamine anti-allergic drugs, cetirizine, domperidone, chlorphenamine maleate, loratadine, meclizine and buclizine in pharmaceutical formulations, human serum and pharmacokinetics application. Anal. Methods. 6. 2704, 2014.
Mohi, I.M.A., S. Sabahuddin, A.U.R. Syed, L. Durdana, D. Shubhasis, and B. Anirbandeep. Simple bioanalytical method development and validation of micronised Domperidone 20 mg tablets using LCMS-MS and its pharmacokinetic application in Healthy Indian Volunteers. Afr. J. Pharm. Pharmacol. 12. 416–420, 2018.
Bayyari, M.A., L.F. Tutunji, N.S. Al-Bayyari, and M.F. Tutunji. Liquid Chromatography Tandem Mass Spectrometry Method for Determination of Domperidone in Human Plasma. J. Chem. Pharm. Res. 7. 980–985, 2015.
Smit, M.J., F.C.W. Sutherland, H.K.L. Hundt, K.J. Swart, A.F. Hundt, and J. Els. Rapid and sensitive liquid chromatography–tandem mass spectrometry method for the quantitation of domperidone in human plasma. J. Chromatogr. A. 949. 65–70, 2002.
Yi, W., and C. Yang. Liquid Chromatography-Electrospray Quadrupole Linear Ion Trap Mass Spectrometric Method for Quantitation of Domperidone in Chinese Healthy Volunteers. Chem.Res.Chinese U. 23. 408–411, 2007.
Zhang, D., K. Chen, Y. Teng, J. Zhang, S. Liu, C. Wei, B. Wang, X. Liu, G. Yuan, R. Zhang, and R. Guo. Determination of Domperidone in Human Plasma using Liquid Chromatography Coupled to Tandem Mass Spectrometry and its Pharmacokinetic Study. Arzneimittelforschung. 62. 128–133, 2012.
Qiu, X. -j, S. -l. Zheng, Y. -f. Wang, R. Wang, and L. Ye. Rapid and Sensitive UPLC-MS/MS Method for the Determination of Domperidone in Human Plasma and its Application to Pharmacokinetic Study. Drug Res (Stuttg). 64. 330–334, 2014.
Wang, X., F. Qin, L. Jing, Q. Zhu, F. Li, and Z. Xiong. Development and validation of UPLC-MS/MS method for determination of domperidone in human plasma and its pharmacokinetic application: UPLC-MS/MS method for determination of domperidone in human plasma. Biomed. Chromatogr. 27. 371–376, 2012.
Xu, D.-H., H.-G. Lou, H. Yuan, B. Jiang, Q. Zhou, Z.-M. Zhang, and Z.-R. Ruan. Quantitative determination of domperidone in human plasma by ultraperformance liquid chromatography with electrospray ionization tandem mass spectrometry. Biomed. Chromatogr. 22. 433–440, 2008.
Moldoveanu, S.C., and V. David. Chapter 7 - RP-HPLC Analytical Columns. Selection of the HPLC Method in Chemical Analysis. 279–328, 2017.
Kobylińska, M., and K. Kobylińska. High-performance liquid chromatographic analysis for the determination of domperidone in human plasma. J. Chromatogr. B Biomed. Appl. 744. 207–212, 2000.
Bose, A., U. Bhaumik, A. Ghosh, B. Chatterjee, U.S. Chakrabarty, A.K. Sarkar, and T.K. Pal. LC–MS Simultaneous Determination of Itopride Hydrochloride and Domperidone in Human Plasma. Chromatographia. 69. 1233–1241, 2009.
Bonfilio, R. Recent applications of analytical techniques for quantitative pharmaceutical analysis: a review. WSEAS Trans. Biol. Biomed. 7. 316–338, 2010.
Nováková, L., L. Matysová, and P. Solich. Advantages of application of UPLC in pharmaceutical analysis. Talanta. 68. 908–918, 2006.
Xu, R.N., L. Fan, M.J. Rieser, and T.A. El-Shourbagy. Recent advances in high-throughput quantitative bioanalysis by LC–MS/MS. J. Pharm. Biomed. Anal. 44. 342–355, 2007.
Crotti, S., I. Isak, and P. Traldi. Chapter 18 - Advanced spectroscopic detectors for identification and quantification: Mass spectrometry. Liquid Chromatography (Second Edition). 431–462, 2017.
Zhang, Y., V. Bala, Z. Mao, Y.S. Chhonker, and D.J. Murry. A concise review of quantification methods for determination of vitamin K in various biological matrices. J. Pharm. Biomed. Anal. 169. 133–141, 2019.
Moein, M.M., A. El Beqqali, and M. Abdel-Rehim. Bioanalytical method development and validation: Critical concepts and strategies. J. Chromatogr. B. 1043. 3–11, 2017.
Youssef, A.S., U.A. Argikar, M. Pathikonda, H.P. Parkman, and S. Nagar. Identification of domperidone metabolites in plasma and urine of gastroparesis patients with LC–ESI-MS/MS. Xenobiotica. 43. 1073–1083, 2013.
Michaud, V., C. Simard, and J. Turgeon. An improved HPLC assay with fluorescence detection for the determination of domperidone and three major metabolites for application to in vitro drug metabolism studies. J. Chromatogr. B. 852. 611–616, 2007.
Lu, W., X. Su, M.S. Klein, I.A. Lewis, O. Fiehn, and J.D. Rabinowitz. Metabolite Measurement: Pitfalls to Avoid and Practices to Follow. Annu Rev Biochem. 86. 277–304, 2017.
