A simple, rapid and stability indicating validated method for quantification of lamotrigine in human plasma and dry plasma spot using LC-ESI–MS/MS: Application in clinical study

Namdev, Kuldeep Kumar; Dwivedi, Jaya; Chilkoti, Deepak Chandra; Sharma, Swapnil

doi:10.1016/j.jchromb.2017.11.040

Cited by 22 publications

(22 citation statements)

References 52 publications

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“…Our method detected with Rts for LTG and IS of 1.6 and 2.0 minutes, respectively, and a total run time of 3.5 minutes. These parameters led to faster determinations than shown in previous reports …”

Section: Discussionsupporting

confidence: 47%

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Determination of lamotrigine in human plasma using liquid chromatography‐tandem mass spectrometry

Shogo

Rina

Nishina

et al. 2019

Neuropsychopharm Rep

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Aim Lamotrigine (LTG) is a widely used anti‐epileptic drug that is administered to avoid seizures and to maintain seizure‐free status. However, several factors reportedly cause individual differences of plasma LTG levels, and the therapeutic target range of LTG varies between individuals. Thus, to optimize effective doses of LTG, we developed a rapid and simple method for determining plasma LTG concentrations. Methods Lamotrigine and the internal standard papaverine were extracted from human plasma using solid‐phase extraction. After filtration, 5‐μL aliquots of final samples were injected into the liquid chromatography‐tandem mass spectrometry instrument and LTG and internal standard were separated using a Cadenza CD‐C18 column (100 × 2 mm, 3 μm) with 0.1% formic acid in water/acetonitrile (2/1, v/v). Results The calibration curve was linear from 0.2 to 5.0 μg/mL, and assessments of recovery, intra‐ and inter‐day precision and accuracy, matrix effects, freeze and thaw stability, and long‐term stability demonstrated good reproducibility. Retention times of LTG and internal standard were 1.6 and 2.0 minutes, respectively, and the total run time was 3.5 minutes for each sample. Conclusion We developed a rapid and simple method for determining plasma LTG concentrations. The present novel system could be used to inform LTG dose adjustments for individual patients.

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Section: Discussionsupporting

confidence: 47%

“…The mass spectra showed the main product ion was the fragment at m/z 43.0, followed by the product ion at m/z 210.8. The product ions at m/z 43.0and 210.8 were also used to measure LTG reported in previous studies. We then selected the product ion at m/z 210.8 for the measurement LTG due to peak forms and quantitative stability.…”

Section: Resultsmentioning

confidence: 99%

Determination of lamotrigine in human plasma using liquid chromatography‐tandem mass spectrometry

Shogo

Rina

Nishina

et al. 2019

Neuropsychopharm Rep

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“…Matrix effects and recovery were assessed by analyzing six sets of standards at three concentrations (1, 5 and 40 ng/mL), similar to the approach used in a previous report (Namdev, Dwivedi, Chilkoti, & Sharma, ; Song et al, ). Matrix effects (ME) for LNG and the IS were assessed by comparing the analyte mean peak areas at three concentration spikes after extracting into blank plasma ( A X ) with the mean peak areas for neat analyte solutions in the mobile phase ( A S ).…”

Section: Methodsmentioning

confidence: 99%

Quantitative determination of levonorgestrel in beagle dog plasma after vaginal administration of intravaginal ring by high‐performance liquid chromatography–tandem mass spectrometry

Liu¹,

Qiu²,

Gu³

et al. 2018

Biomedical Chromatography

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A specific and sensitive high-performance liquid chromatography-tandem mass spectrometry method that could be used to determine the concentration of levonorgestrel (LNG) in beagle dog plasma was developed. Specifically, terfenadine was used as the internal standard (IS). The separation was achieved on a Kinetex-C 110A column (3 × 30 mm i.d., 2.6 um, Phenomenex) and a gradient mobile phase consists of methanol (0.1% formic acid) and water (0.1% formic acid) was used. The flow rate was 0.8 mL/min and the injection volume was 10 μL. The detection was performed on a triple-quadruple tandem mass spectrometer by multiple reaction monitoring mode via electrospray ionization. Quantitative analysis was carried out at m/z 313.0 → 108.9 and m/z 472.6 → 436.2 for LNG and IS respectively. This method demonstrated the linearity of LNG over a concentration range of 0.5-50 ng/mL with a coefficient correlation (r) of 0.9973. The lower limit of quantification was 0.5 ng/mL. The intra- and inter-assay precisions were 2.9 and 11.2%, with an accuracy range from 94.8 to 108.4%. The stability data indicated that sample preparation and storage process had little effect on the concentration of LNG QC sample. The validated method was successfully applied to study the pharmacokinetics of LNG in beagle dog after vaginal administration of intravaginal ring.

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confidence: 99%

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2018

IJPSR

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Bioanalysis is a sub-discipline of analytical chemistry covering the quantitative measurement of xenobiotics (drugs and their metabolites and biological molecules in unnatural locations or concentration) and biotics (macromolecules, proteins, DNA, large molecule drugs, metabolites) in biological system. The focus of bioanalysis in the pharmaceutical industry is to provide as quantitative measure of the active drug and/or its metabolite(s) for the purpose of pharmacokinetics, toxicokinetics, bioequivalence and exposure response (pharmacokinetics / pharmacodynamics studies). Over the past several years dried matrix spot (DMS) sampling technique has emerged as a pertinent method in both qualitative and quantitative bioanalysis context. There are many types of DMS techniques such as dried blood spot (DBS), dried plasma spot (DPS), dried urine spot (DUS) and dried breast milk spot (DBMS). The most commonly used technique is DBS wherein the blood sample is directly soaked on to a paper (with or without treatment) and after drying it can be analyzed by modern analytical, immunological or genomic detection systems. Several advantages of DMS techniques such as low sample requirement, transportation and storage without special treatment, better analytes stability, enhanced clinical cooperation in clinical trials and reduced unforeseeable exposure of biohazard to analysts, make it the most appropriate sampling technique for bioanalysis. This review illustrates the available information on DBS, DPS, DUS and DBMS methods which may serve for investigators in the field of bioanalysis. Further, the proficiency and appliance of DMS method in pharmacokinetic (PK), therapeutic drug monitoring (TDM), toxicokinetic (TK), metabolomic and disease diagnosis is explored.

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A simple, rapid and stability indicating validated method for quantification of lamotrigine in human plasma and dry plasma spot using LC-ESI–MS/MS: Application in clinical study

Cited by 22 publications

References 52 publications

Determination of lamotrigine in human plasma using liquid chromatography‐tandem mass spectrometry

Determination of lamotrigine in human plasma using liquid chromatography‐tandem mass spectrometry

Quantitative determination of levonorgestrel in beagle dog plasma after vaginal administration of intravaginal ring by high‐performance liquid chromatography–tandem mass spectrometry

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