Quantitative determination of domperidone in human plasma by ultraperformance liquid chromatography with electrospray ionization tandem mass spectrometry

Abstract

A simple and sensitive liquid chromatography-tandem mass spectrometry method was developed and validated for determining domperidone in human plasma. The analyte and internal standard (IS; mosapride) were isolated from plasma samples by protein precipitation with methanol (containing 0.1% formic acid). The chromatographic separation was performed on an Xterra MS C(18) Column (2.1 x 150 mm, 5.0 microm) with a gradient programme mobile phase consisting of 0.1% formic acid and acetonitrile at a flow rate of 0.30 mL/min. The total run time was 4.0 min. The analyses were carried out by multiple reaction monitoring using the parent-to-daughter combinations m/z 426 --> 175 and m/z 422 --> 198 (IS). The areas of peaks from the analyte and IS were used for quantification of domperidone. The method was validated according to the FDA guidelines on bioanalytical method validation. Validation results indicated that the lower limit of quantification was 0.2 ng/mL, and the assay exhibited a linear range of 0.2-60.0 ng/mL and gave a correlation coefficient (r(2)) of 0.999 or better. Quality control samples (0.4, 0.8, 15 and 50 ng/mL) in six replicates from three different analytical runs demonstrated an intra-assay precision (RSD) 4.43-6.26%, an inter-assay precision 5.25-7.45% and an overall accuracy (relative error) of <6.92%. The method can be applied to pharmacokinetic and bioequivalence studies of domperidone.

Determination of domperidone in human plasma using high performance liquid chromatography with fluorescence detection for clinical application

“…Kobilińska et al previously reported an HPLC method using solid-phase extraction (SPE), which required a post-column photoderivatization for fluorescence detection [9]. Recently, Xu et al proposed an LC-MS/MS method with direct injection after simple protein precipitation [7]. LC-MS/MS method could be the best choice in terms of sensitivity and specificity, but this equipment is not always available in many laboratories.…”

“…Several HPLC methods have been reported for the determination of domperidone in plasma [6][7][8][9][10][11][12]. Most of these methods required time-consuming laborious liquid-liquid Page 4 of 30 A c c e p t e d M a n u s c r i p t -3 -extraction procedures [6,8,10,12].…”

Simultaneous determination of triptolide, tripdiolide and tripterine in human urine by high‐performance liquid chromatography coupled with ion trap atmospheric‐pressure chemical ionization mass spectrometry

“…These methods lack of sensitivity and require extensive sample preparation before analysis. Mass spectrometry has played an important role in toxicology due to its sensitivity, rapidity and low levels of sample consumption for the characterization and determination of many toxic compounds (Cao et al, 2008;Chou et al, 2008;Jin and Chen, 2006;Jin et al, 2007;Li et al, 2008;Xiao et al, 2008;Xu et al, 2008;Yao et al, 2006). Recently, Shao et al (Shao et al, 2006) developed an analytical assay to detect triptolide in dog plasma samples by high-performance liquid chromatography coupled with atmosphericpressure-chemical ionization mass spectrometry (HPLC-APCI-MS).…”

Simultaneous determination of udenafil and its active metabolite, DA‐8164, in human plasma and urine using ultra‐performance liquid chromatography–tandem mass spectrometry: application to a pharmacokinetic study

“…Compared with HPLC, ultra-performance liquid chromatography (UPLC) is a relatively new technique using analytical Bridged Ethane Hybrid (BEH) C 18 columns packed with 1.7 μm particles, mobile phases at high linear velocities, and instrumentation that operates at high pressure. UPLC, therefore, offers the advantages of increased speed during analysis, higher sensitivity and greater resolution for analytical determination, particularly when coupled with mass spectrometry (O'Conner and Mortishire-Smith, 2006;Li et al, 2007;Mensch et al, 2007;Xu et al, 2007).…”