Beyza Sultan AYDIN, İbrahim BULDUK

A Validated HPLC-UV Method for Determination of Dopamine HCl in Injectable Solutions

Dopamine is a neurotransmitter that acts in the nervous system as a chemical messenger, which helps specific neurons to interact with each other. A simple, precise, accurate HPLC method has been developed and validated for determination of Dopamine HCl (DOPHCl) in pharmaceutical formulations. Separation was performed on a C18 column (250 x 4.6 mm, 5 μm) with 50 mM potassium dihydrogen phosphate (pH 2.3) as a mobile phase. Mobile phase flow rate was maintained constant at 1 mL min-1. High sensitivity has been achieved with UV detection at 280 nm. Parameters such as interaction of the active pharmaceutical ingredient and excipients, linearity and repeatability were investigated during analytical method development. Retention time was 6.195 min for DOPHCl. The method has been validated for DOPHCl within the range of 20-100 μg mL-1 (r2=0.9998). This method has shown strong reproducibility and recovery within the determined range. This method can be used successfully in pharmaceutical formulations for routine analysis.

Keywords:

Dopamin HCl, HPLC Method, Validation,

PDF

___

Berridge KC, Robinson TE. 1998. What is the role of dopamine in reward: hedonic impact, reward learning, or incentive salience? Brain Res. Rev., 28(3): 309-369.
Cannazza G, Stefano AD, Mosciatti B. 2005. Detection of levodopa, dopamine and its metabolites in rat striatum dialysates following peripheral administration of l-DOPA prodrugs by mean of HPLC–EC, J. Pharm. Biomed. Anal. 36(5): 1079–1084.
Carrera V, Sabater E, Vilanova E. 2007. A simple and rapid HPLC–MS method for the simultaneous determination of epinephrine, norepinephrine, dopamine and 5 hydroxytryptamine: application to the secretion of bovine chromaffin cell cultures, J. Chromatogr. B, 847(2): 88–94.
Center for Drug Evaluation and Research (CDER). (1994). Reviewer Guidance: Validation of Chromatographic Methods. CMC, 3.
Damase-Michel C, Montastruc JL. 1995. Tran Effects of dopaminergic drugs on the sympathoadrenal system. Hypertens Res. 18:119-S124.
Ferreira FDP, Silva LIB, Freitas AC. 2009. High performance liquid chromatography coupled to an optical fiber detector coated with laccase for screening catecholamines in plasma and urine. J. Chromatogr. A. 1216 (42):7049–7054.
Fujino K, Yoshitake S, Kehr J. 2003. Simultaneous determination of 5-hydroxyindoles and catechols by high-performance liquid chromatography with fluorescence detection following derivatization with benzylamine and 1.2-diphenylethylenediamine, J. Chromatogr. A, 1012(2): 169–177.
Guo L, Zhang Y, Li Q. 2009. Spectrophotometric determination of dopamine hydrochloride in pharmaceutical, banana, urine and serum samples by potassium ferricyanide-Fe (III). Anal Sci. 25(12):1451-1455.
Gupta R, Goyal RN, Shim YB. 2015. Simultaneous analysis of dopamine and 5-hydroxyindoleacetic acid at nanogold modified screen printed carbon electrodes. Sensors and Actuators B, Chemical, 213:72–81.
Haldorai Y, Vilian AE, Rethinasabapathy M, Huh YS, Han YK. 2017. Electrochemical determination of dopamine using a glassy carbon electrode modified with tin-reduced graphene oxide nanocomposite. Sensors and Actuators B: Chemical, 247:61–69.
Hussain T, Lokhandwala MF. 2003. Renal Dopamine Receptors and Hypertension. Experimental Biology and Medicine, 228(2):134–142.
ICH. 2005. Q2 (R1), harmonized tripartite guideline, validation of analytical procedures: text and methodology, In Proceedings of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Ivan G, Szigeti-Csucs N, Olah M, Nagy GM, Goth MI. 2005. Treatment of pituitary tumors: dopamine agonists. Endocrine, 28(1):101-110.
Jose PA, Eisner GM, Felder RA. 1998. Renal dopamine receptors in health and hypertension. Pharmacol Ther. 80:149–182.
Liu GS, Chen JN, Ma YF. 2004. Simultaneous determination of catecholamines and polyamines in PC-12 cell extracts by micellar electrokinetic capillary chromatography with ultraviolet absorbance detection, J. Chromatogr. B, 805(2):281–288.
McKenzie JAM, Watson CJ, Rostand RD. 2002. Automated capillary liquid chromatography for simultaneous determination of neuroactive amines and amino acids, J. Chromatogr. A, 962 (1-2), 105–115.
Neve KA. 2010. The Dopamine Receptors, Humana Press, 585-597.
Palanisamy S, Thirumalraj B, Chen SM, Ajmal Ali M, Muthupandi K, Emmanuel R, Prakash P, Al‐Hemaid F. 2015. Fabrication of silver nanoparticles decorated on activated screen-printed carbon electrode and its application for ultrasensitive detection of dopamine. Electroanalysis, 27 (8), 1998–2006.
Silva LIB, Ferreira FDP, Freitas AC. 2009. Optical fiber biosensor coupled to chromatographic separation for screening of dopamine, norepinephrine and epinephrine in human urine and plasma. Talanta, 80 (2):853–857.
Sultan SC, Sezer E, Tepeli Y, Anik U. 2014. Centri-voltammetric dopamine detection. RSC Advances, 4 (59), 31489–92. Talanta, 76 (3):690–697.
Yoshitake T, Yoshitake S, Fujino K. 2004. High-sensitive liquid chromatographic method for determination of neuronal release of serotonin, noradrenaline and dopamine monitored by microdialysis in the rat prefrontal cortex. J. Neurosci. Methods, 140 (1–2):163–168.
Zhao XE, Suo YR. 2008. Simultaneous determination of monoamine and amino acid neurotransmitters in rat endbrain tissues by precolumn derivatization with high-performance liquid chromatographic fluorescence detection and mass spectrometric identification.