Development, validation, and application of a simple UPLC–MS/MS method for simultaneous quantification of five traditional antipsychotics in human plasma

Fan, Liju; An, Jing; Cui, Yanjun; Dong, Zhanjun

doi:10.1002/bmc.5143

Cited by 4 publications

(1 citation statement)

References 31 publications

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“…Various methods have been employed to detect PMZ, including enzyme-linked immunosorbent assay [13,14], spectroscopy [15][16][17], capillary electrophoresis [18,19], high performance liquid chromatography [20,21], gas chromatography-mass spectrometry [22][23][24][25][26][27][28][29], and liquid chromatography-tandem mass spectrometry (LC-MS/MS) [30][31][32][33][34][35][36][37][38][39][40][41][42][43]. However, most of the reported detection methods are used for PMZ formulations or detecting illegally added PMZ in animal feed [32,35,44,45].…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of a High-Performance Liquid Chromatography–Tandem Mass Spectrometry Method to Determine Promethazine and Its Metabolites in Edible Tissues of Swine

Wen

Shi

et al. 2023

Foods

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This study aimed to determine promethazine (PMZ) and its metabolites, promethazine sulfoxide (PMZSO) and monodesmethyl-promethazine (Nor1PMZ), in swine muscle, liver, kidney, and fat. A sample preparation method and high-performance liquid chromatography–tandem mass spectrometry (LC–MS/MS) analysis were established and validated. The samples were extracted using 0.1% formic acid–acetonitrile and purified with acetonitrile-saturated n-hexane. After concentration by rotary evaporation, the extract was re-dissolved in a mixture of 0.1% formic acid-water and acetonitrile (80:20, v/v). Analysis was performed using a Waters Symmetry C18 column (100 mm × 2.1 mm i.d., 3.5 μm) with 0.1% formic acid–water and acetonitrile as the mobile phase. The target compounds were determined using positive ion scan and multiple reaction monitoring. PMZ and Nor1PMZ were quantified with deuterated promethazine (PMZ-d6) as the internal standard, while PMZSO was quantified using the external standard method. In spiked muscle, liver, and kidney samples, the limits of detection (LOD) and limits of quantification (LOQ) for PMZ and PMZSO were 0.05 μg/kg and 0.1 μg/kg, respectively, while for Nor1PMZ, these values were 0.1 μg/kg and 0.5 μg/kg, respectively. For spiked fat samples, the LOD and LOQ for all three analytes were found to be 0.05 μg/kg and 0.1 μg/kg, respectively. The sensitivity of this proposed method reaches or exceeds that presented in previous reports. The analytes PMZ and PMZSO exhibited good linearity within the range of 0.1 μg/kg to 50 μg/kg, while Nor1PMZ showed good linearity within the range of 0.5 μg/kg to 50 μg/kg, with correlation coefficients (r) greater than 0.99. The average recoveries of the target analytes in the samples varied from 77% to 111%, with the precision fluctuating between 1.8% and 11%. This study developed, for the first time, an HPLC–MS/MS method for the determination of PMZ, PMZSO, and Nor1PMZ in four swine edible tissues, comprehensively covering the target tissues of monitoring object. The method is applicable for monitoring veterinary drug residues in animal-derived foods, ensuring food safety.

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Section: Introductionmentioning

confidence: 99%

Development and Validation of a High-Performance Liquid Chromatography–Tandem Mass Spectrometry Method to Determine Promethazine and Its Metabolites in Edible Tissues of Swine

Wen

Shi

et al. 2023

Foods

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A validated stability‐indicating reversed‐phase‐UPLC method for simultaneous estimation of promethazine hydrochloride, methylparaben, propylparaben and sodium benzoate assay of cough suppressant and antihistamine liquid oral dosage forms

Pippalla,

Nekkalapudi,

Komreddy

2024

Biomedical Chromatography

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A quick, simple, sensitive, efficient and stability‐indicating reverse‐phase ultraperformance liquid chromatographic method for the estimation of propylparaben, methylparaben and sodium benzoate in a pharmaceutical liquid oral formulation was developed. A Waters Acquity UPLC BEH C18, 50 × 2.1 mm, 1.7 μm i.d. column was used to perform chromatographic separation with a 0.1% perchloric acid mobile phase used as solvent A and a mixture of 0.1 % perchloric acid and methanol in the ratio 20:80 (v/v), respectively, as solvent B. The experiments were carried out at a flow rate of 0.4 ml/min and the detection wavelength was 240 nm. The compartment temperature of the column was set at 40°C and the injection volume was set at 2 μl. The main aim of the research was to develop a single UPLC assay method for promethazine (active ingredient) and preservatives in the oral solution of promethazine HCl and dextromethorphan HBr that contains promethazine (active ingredient) and methylparaben, propylparaben and sodium benzoate (preservatives). An assay of dextromethorphan HBr was developed and validated by another HPLC method. The drug and preservatives were eluted at retention times of 19.3 min for promethazine HCl, 9.3 min for methylparaben, 18.9 min for propylparaben and 8.9 min for sodium benzoate. Validation of the developed method was carried out as stated by the International Conference on Harmonization guidelines ICH Q2B and under USP<1225>. The analytical parameters verified specificity/selectivity, linearity, accuracy, ruggedness and robustness. The linearity ranges of promethazine HCL, methylparaben, propylparaben and sodium benzoate were 10–100, 10–80, 1.0–8.0 and 10–80 μg/ml, respectively, with a correlation coefficient of active ingredients and preservatives of 1.00. Percentage recoveries of promethazine, propylparaben, methylparaben, and sodium benzoate were 100.0–100.2, 99.0–100.3, 99.5–98.0 and 99.0–100.0%. The validated analytical method proves that the method is specific, precise, linear, accurate, sensitive, rugged and stable, indicating the quantification of the active ingredient and all preservatives in liquid oral formulations.

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Development of a simultaneous LC–MS/MS analytical method for plasma: 16 antipsychotics approved in Japan and 4 drug metabolites

Maekawa,

Yokota,

Sato

et al. 2024

ANAL. SCI.

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The increased risk of adverse drug reactions due to the concomitant use of antipsychotics is problematic in the treatment of schizophrenia. Therefore, the simultaneous analysis of their plasma concentrations is required. In this study, we developed a simultaneous liquid chromatography/tandem mass spectrometry (LC–MS/MS) method for analyzing plasma antipsychotics approved in Japan for therapeutic drug monitoring (TDM) applications. First, we counted the prescriptions for 16 antipsychotics and concomitant drugs used at the Tohoku University Hospital. LC–MS/MS was used for the simultaneous analysis of 16 antipsychotics and four drug metabolites. This analysis was conducted using a combination of selected reaction monitoring mode and reversed-phase chromatography. Following the examination of the MS/MS and LC conditions, an analytical method validation test was conducted. The developed method was used to analyze plasma antipsychotic levels in patients with schizophrenia. One-third of the patients received treatment with multiple antipsychotics. Under LC–MS/MS conditions, LC separation was performed using a combination of a C18 column and ammonium formate-based mobile phases with a gradient flow. The calibration curves were optimized by adjusting the ion abundance, and 11 compounds met the criteria for intra- and inter-day reproducibility tests. Some stability test results did not meet these criteria; therefore, further investigation is required. The developed method permitted the measurement of all the plasma parameters, including concentrations above the therapeutic range. Therefore, this method may be useful in the daily TDM practice of antipsychotics. Graphical abstract

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Development, validation, and application of a simple UPLC–MS/MS method for simultaneous quantification of five traditional antipsychotics in human plasma

Cited by 4 publications

References 31 publications

Development and Validation of a High-Performance Liquid Chromatography–Tandem Mass Spectrometry Method to Determine Promethazine and Its Metabolites in Edible Tissues of Swine

Development and Validation of a High-Performance Liquid Chromatography–Tandem Mass Spectrometry Method to Determine Promethazine and Its Metabolites in Edible Tissues of Swine

A validated stability‐indicating reversed‐phase‐UPLC method for simultaneous estimation of promethazine hydrochloride, methylparaben, propylparaben and sodium benzoate assay of cough suppressant and antihistamine liquid oral dosage forms

Development of a simultaneous LC–MS/MS analytical method for plasma: 16 antipsychotics approved in Japan and 4 drug metabolites

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