Abstract
A simple and sensitive fluorescence detection of domperidone by ultra fast liquid chromatographic method was developed and validated in human serum. For the evaluation of new drug delivery systems, conducting of pharmacokinetic studies in human volunteers is essential for approval to marketing after preclinical evaluation in animal models. The present method consists of protein precipitation, extraction of analytes from human serum into dichloromethane and separation using reversed-phase C18 column. Propranolol hydrochloride was used as an internal standard and the eluent was monitored by fluorescence detector at excitation 282 and emission 328 nm. The mobile phase used was 62:38 ratio of 10 mM phosphate buffer pH adjusted to 3.1 with OPA and methanol at a flow rate of 1 mL·min-1. The method was evaluated for assay, LLOD, LLOQ, recovery and stability studies. The retention times for domperidone and propranolol hydrochloride were found to be 6.36 and 7.94 minutes respectively. The intraday and inter-day coefficient of variation and percent error values of assay method were less than 5%; mean recovery was more than 96% for each analyte and the method was found to be precise, accurate and specific during study. The method was successfully applied for pharmacokinetic study of immediate and controlled release bioadhesive hot melt extruded buccal patches of domperidone after buccal administration to healthy human volunteers. The Cmax, Tmax, and AUC0–24 of domperidone from immediate and controlled release buccal patches were found to be 129.7 ng·mL-1, 1.5 h, 455.1 ng·h·mL-1 and 145.7 ng·mL-1, 5.25 h, 911.0 ng·h·mL-1 respectively. A simple, sensitive and reliable method for the fluorescence determination of domperidone in human serum by UFLC method was developed and validated.
Highlights
Domperidone (DOM) is a dopamine-receptor (D2) antagonist
Literature survey reveals that several simultaneous methods have been used for quantification of DOM using high-performance liquid chromatography (HPLC) in tablet formulation [3]-[7]; in rat serum samples using HPLC with fluorescence detection [8], in human serum and human breast milk by electrospray mass spectrometry and by fluorescence detector [9] [10] and 14C-labelled radio activity method for excretion and metabolism in animals and men [11]
The results suggest that DOM in stock solutions were stable for at least 14 days when stored at 4 ̊C and for 12 h at room temperature
Summary
5-chloro-1-[1-[3-(2-oxo-2,3-dihydro1H-benzimidazol-11-yl)propyl]-piperidin-4-yl]-1,3-dihydro-2H-benzimidazol-2-one and Propranolol HCl (PH) is 1-naphthalen-1-yloxy-3-(propan-2-ylamino) propan-2-ol; hydrochloride. It is widely used in the treatment of motion-sickness, increasing lower esophageal sphincter pressure, further preventing nausea and vomiting and prompting gastrointestinal motility [1]. Liquid chromatography tandem mass spectrometry chromatographic method in human plasma [12] [13] and spectroscopic study for conformational analysis [14] was reported. The content of the present work was to develop and optimize a simple ultra fast liquid chromatography (UFLC) method with fluorescence detection for the determination of DOM in human serum was developed. The present method was successfully applied for the study of pharmacokinetics of DOM from bioadhesive buccal patches in humans.
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