Liquid chromatography high resolution mass spectrometry for the determination of baclofen and its metabolites in plasma: Application to therapeutic drug monitoring

Labat, Laurence; Goncalves, Antonio; Marques, Ana Rita Lopes; Duretz, Bénédicte; Granger, Bernard; Declèves, Xavier

doi:10.1002/bmc.3936

Cited by 16 publications

(6 citation statements)

References 19 publications

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“…Maternal and newborn baclofen and creatinine plasma levels were measured in blood samples at H0 of life (umbilical cord vein), H11, H31, and H102. Creatinine levels were determined using enzymatic reaction, and baclofen concentrations were measured with an in-house validated method [6]. Plasma baclofen concentration of the mother 9 h before delivery was 280 ng/mL (2.5 h after dose intake), and concentrations of the neonate were 205, 105, 24, and below 10 ng/mL (the lower limit of quantification, LLOQ), at H0, H11, H31, and H102, respectively (shown in Fig.…”

Section: Case Report/case Presentationmentioning

confidence: 99%

Pharmacokinetics of Baclofen in a Full-Term Newborn after Intrauterine Exposure: A Case Report

et al. 2021

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Intrauterine exposure to baclofen can lead to syndrome of withdrawal during the first days of the newborn. We report the case of a full-term baby exposed to baclofen during pregnancy. The mother was treated with baclofen 10 mg 4 times daily. Blood samples were collected from the mother before entering labor and from the baby at H0, H11, H31, and H102 after birth to measure baclofen concentrations and monitor its elimination. Baclofen maternal and neonate pharmacokinetics (PK) and placental transfer were assessed using a physiologically based PK model. Baclofen PK in the neonate after birth followed a monoexponential elimination with a half-life of 10 h, 3-fold longer than that in adults. The newborn was monitored for 11 days without experiencing any symptoms of withdrawal. Reducing baclofen dosing regimen of the mother to the lowest and therefore reducing fetal exposure to baclofen is essential. This case reports for the first time the baclofen pharmacokinetic profile in a newborn.

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Section: Case Report/case Presentationmentioning

confidence: 99%

Pharmacokinetics of Baclofen in a Full-Term Newborn after Intrauterine Exposure: A Case Report

et al. 2021

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“…Beside the different methods of the Pharmacopoeias, several methods for the content determination of baclofen are reported in the literature [13][14][15]. However, methods for impurity profiling of baclofen are quite rare.…”

Section: Introductionmentioning

confidence: 99%

“…A and imp. B [16]. Elagawany et al described a TLC method for the determination of at least two baclofen impurities [17], which can be considered as outdated, because of the typically low sensitivity of TLC.…”

Section: Introductionmentioning

confidence: 99%

Impurity Profiling of Baclofen Using Gradient HPLC–UV Method

Leistner

Holzgrabe

2021

Chromatographia

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The GABAB receptor agonist baclofen is a medication commonly used for the treatment of muscle spasticity. It is an amino acid and related to the neurotransmitter GABA. In this study, we developed a new, gradient high-performance liquid chromatography (HPLC) method for the impurity assessment of baclofen, which is appropriate for pharmacopoeial purposes. Since the impurities related to the synthesis pathway are acids, zwitterionic, or neutral, the method development is challenging. However, the separation of all components was achieved on a C18 stationary phase using a water–acetonitrile–trifluoroacetic acid gradient. A limit of detection (LOD) of at least 0.02% was registered for all specified impurities. Additionally, CAD detection was performed to detect potential impurities lacking off a chromophore. The baclofen batches analyzed are far more pure than expected. All impurities were found below the specification limit, and thus, they can be regarded as unspecified. Moreover, the required runtime could be significantly reduced compared to the current USP or Ph. Eur. method.

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“…Thorough literature survey revealed that chromatographic methods, mainly HPLC, are the mostly used methods for BAC analysis. Such as, HPLC with UV detection [2], determination in human plasma by HPLC with several detection methods including tandem mass spectrometry (MS-MS) [3, 4], high-resolution mass spectrometry (HR-MS) [5] and fluorescence detection [6, 7]. In addition, ultra-performance liquid chromatography coupled with MS-MS detection has been used for detecting BAC in blood samples [8].…”

Section: Introductionmentioning

confidence: 99%

Simple mix-and-read assays for the determination of baclofen in pharmaceutical formulation

El-Yazbi

Guirguis

Bedair

et al. 2019

Heliyon

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This study demonstrates three simple and inexpensive spectrophotometric mix-and-read assays for the determination of the skeletal muscle relaxant, baclofen (BAC) in pharmaceutical formulations. The proposed methods are based on the reaction of the primary amine group of BAC with various derivatizing reagents to yield different colored products. Method I depends on the reaction of BAC with vanillin in borate buffer pH 11.5 to give a yellow colored product with maximum absorbance at 401 nm. While method II describes the reaction with eosin Y in citric-phosphate buffer pH 2.2 forming an orange-red product measured at 548 nm. Method III depends on Hantzsch condensation reaction that yields a yellow product measured at 339 nm. Different experimental variables influencing development and stability of the obtained colored product are optimized. Validation of the three methods regarding linearity, ranges, precision, accuracy and limits of detection and quantification was performed. Regression analysis showed good linearity over the concentration ranges of 10–35, 5–20 and 5–25 μg/mL for methods I, II and III, respectively with correlation coefficient values not less than 0.999. Additionally, detection limits of BAC are 1.58, 0.94 and 0.79 μg/mL for methods I, II and III, respectively. Finally, the suggested procedures are successfully used for assay of BAC in its tablets. The main advantages of the proposed mix-and-read assays are being inexpensive and rapid with no requirement for laborious extraction techniques with equivalent or superior sensitivity compared to other published spectrophotometric procedures. Such advantages promote the suggested methods for the high throughput assay of BAC dosage forms, a critical component in quality control studies for pharmaceutical industries.

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Liquid chromatography high resolution mass spectrometry for the determination of baclofen and its metabolites in plasma: Application to therapeutic drug monitoring

Cited by 16 publications

References 19 publications

Pharmacokinetics of Baclofen in a Full-Term Newborn after Intrauterine Exposure: A Case Report

Pharmacokinetics of Baclofen in a Full-Term Newborn after Intrauterine Exposure: A Case Report

Impurity Profiling of Baclofen Using Gradient HPLC–UV Method

Simple mix-and-read assays for the determination of baclofen in pharmaceutical formulation

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