Validation and Quantification of Domperidone in Spiked Plasma Matrix Using Reversed Phase HPLC-UV Method

Sekar Ayu Pawestri(1), Akhmad Kharis Nugroho(2*), Endang Lukitaningsih(3), Purwantiningsih Purwantiningsih(4)

(1) Department of Pharmaceutics, Faculty of Pharmacy, Universitas Gadjah Mada, Yogyakarta 55281, Indonesia
(2) Department of Pharmaceutics, Faculty of Pharmacy, Universitas Gadjah Mada, Yogyakarta 55281, Indonesia
(3) Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Universitas Gadjah Mada, Yogyakarta 55281, Indonesia
(4) Department of Pharmacology and Clinical Pharmacy, Faculty of Pharmacy, Universitas Gadjah Mada, Yogyakarta 55281, Indonesia
(*) Corresponding Author


Pharmacokinetics studies of domperidone generally analyze plasma matrix samples. The present work aimed to develop and validate a rapid and simple reversed phase-HPLC method for quantifying domperidone in plasma matrices. The chromatographic method implemented: 1. Luna Phenomenex® C18 (250 mm × 4.6 mm i.d; 5 µm) column, 2. isocratic mobile phase mixture of phosphate buffer 0.02 M:acetonitrile (70:30, v/v) with a flow rate of 1 mL/min, 3. UV detection at 285 nm. Domperidone and propranolol hydrochloride (as internal standard) were extracted from the deproteinated plasma sample. The method linearity was 0.998 in the range concentration of 15–200 ng/mL. The percentage of accuracy error was between -8.49–4.31%, while the percentage coefficient variation of precision ranged between 5.11–14.24%. This proposed method was simple, rapid (separation time less than 10 min), and selective. The validation parameters responses satisfied the method's requirements to determine domperidone in a plasma sample.


domperidone; RP-HPLC; spiked plasma; validation

Full Text:

Full Text PDF


[1] Athukuri, B.L., and Neerati, P., 2017, 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.

[2] Helmy, S.A., and El Bedaiwy, H.M., 2014, Pharmacokinetics and comparative bioavailability of domperidone suspension and tablet formulations in healthy adult subjects, Clin. Pharmacol. Drug Dev., 3 (2), 126–131.

[3] Khan, A., Iqbal, Z., Khadra, I., Ahmad, L., Khan, A., Khan, M.I., Ullah, Z., and Ismail, 2016, 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.

[4] Yamamoto, K., Hagino, M., Kotaki, H., and Iga, T., 1998, Quantitative determination of domperidone in rat plasma by high-performance liquid chromatography with fluorescence detection, J. Chromatogr. B: Biomed. Sci. Appl., 720 (1-2), 251–255.

[5] Bayyari, M.A., Tutunji, L.F., Al-Bayyari, N.S., and Tutunji, M.F., 2015, Liquid chromatography tandem mass spectrometry method for determination of domperidone in human plasma, J. Chem. Pharm. Res., 7 (1), 980–985.

[6] Smit, M.J., Sutherland, F.C.W., Hundt, H.K.L., Swart, K.J., Hundt, A.F., and Els, J., 2002, Rapid and sensitive liquid chromatography–tandem mass spectrometry method for the quantitation of domperidone in human plasma, J. Chromatogr. A, 949 (1-2), 65–70.

[7] Ali, I., Gupta, V.K., Singh, P., and Negi, U., 2014, SPE-HPLC techniques for separation and identification of domperidone in human plasma, J. Liq. Chromatogr. Relat. Technol., 37 (18), 2587–2597.

[8] Abdul, M.I.M, Siddique, S., Ur Rahman, S.A., Lateef, D., Dan, S., and Bose A., 2018, 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 (27), 416–420.

[9] Wu, Y., Chu, Y., Zhang, Y., Wu, D., Gu, J., 2007, Liquid chromatography-electrospray quadrupole linear ion trap mass spectrometric method for quantitation of domperidone in Chinese healthy volunteers, Chem. Res. Chin. Univ., 23 (4), 408–411.

[10] Bose, A., Bhaumik, U., Ghosh, A., Chatterjee, B., Chakrabarty, U.S., Sarkar, A.K., and Pal, T.K., 2009, LC–MS simultaneous determination of itopride hydrochloride and domperidone in human plasma, Chromatographia, 69 (11), 1233–1241.

[11] Abbas, G., Saadullah, M., Rasul, A., Shah, S., Khan, S.M., Hanif, M., and Ahmed, M.M., 2020, Development and validation of high-performance liquid chromatography method for the simultaneous monitoring of pantoprazole sodium sesquihydrate and domperidone maleate in plasma and its application to pharmacokinetic study, Acta Chromatogr., 32 (3), 157–165.

[12] Yoshizato, T., Tsutsumi, K., Kotegawa, T., Imai, H., and Nakano, S., 2014, Determination of domperidone in human plasma using high performance liquid chromatography with fluorescence detection for clinical application, J. Chromatogr. B, 961, 86–90.

[13] Qiu, X.J., Zheng, S.L., Wang, Y.F., Wang, R., and Ye, L., 2014, Rapid and sensitive UPLC-MS/MS method for the determination of domperidone in human plasma and its application to pharmacokinetic study, Drug Res., 64 (6), 330–334.

[14] Wang, X., Qin, F., Jing, L., Zhu, Q., Li, F., and Xiong, Z., 2012, 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 (3), 371–376.

[15] Palem, C.R., Goda, S., Dudhipala, N.R., and Yamsani, M.R., 2016, Development of ultra fast liquid chromatography (UFLC) method for fluorescence detection of domperidone in human serum and application to pharmacokinetic study, Am. J. Anal. Chem., 7, 12–21.

[16] Zhang, D., Chen, K., Teng, Y., Zhang, J., Liu, S., Wei, C., Wang, B., Liu, X., Yuan, G., Zhang, R., and Guo, R., 2012, Determination of domperidone in human plasma using liquid chromatography coupled to tandem mass spectrometry and its pharmacokinetic study, Arzneimittelforschung, 62 (3), 128–133.

[17] Purba, N.B.R., Rohman, A., and Martono, S., 2019. Validation and application of reversed-phase high-performance liquid chromatography for quantitative analysis of Acid Orange 7 and Sudan II in blusher products, J. Appl. Pharm. Sci., 9 (7), 100–105.

[18] EMA, 2011, Guideline on Bioanalytical Method Validation, European Medicines Agency, London, United Kingdom.

[19] Kohler, I., Schappler, J., and Rudaz, S., 2013, Microextraction techniques combined with capillary electrophoresis in bioanalysis, Anal. Bioanal. Chem., 405 (1), 125–141.

[20] Lakshmana, S., and Suriyaprakash, T.N.K., 2012, “Extraction of drug from the biological matrix: A review” in Applied Biological Engineering, Eds. Naik, G.R., InTechOpen, Rijeka, Croatia, 479–506.

[21] Wiraagni, I.A., Mohd, M.A., bin Abd Rashid, R., bin Mohamad Haron, D.E., 2019, Validation of a simple extraction procedure for bisphenol A identification from human plasma, PLoS One, 14 (10), e0221774.

[22] Veigure, R., Lossmann, K., Hecht, M., Parman, E., Born, R., Leito, I., Herodes, K., and Kipper, K., 2020, 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.

[23] Notario, D., Martono, S., Ikawati, Z., Hakim, A.R., Jannah, F., and Lukitaningsih, E., 2017, A rapid and simple high-performance liquid chromatographic method for determination of levofloxacin in human plasma, Indones. J. Chem., 17 (1), 54–62.

[24] Wei, X., Pang, Z., Fan, G., Xu, X., and Wang, L., 2018, Simultaneous prediction of retention times and peak shapes of sulfonamides in reversed-phase high-performance liquid chromatography, Trans. Tianjin Univ., 24 (3), 256–262.


Article Metrics

Abstract views : 1354 | views : 1222

Copyright (c) 2021 Indonesian Journal of Chemistry

Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.


Indonesian Journal of Chemistry (ISSN 1411-9420 / 2460-1578) - Chemistry Department, Universitas Gadjah Mada, Indonesia.

Analytics View The Statistics of Indones. J. Chem.