Assessment of critical extraction and chromatographic parameters for the determination of bupropion and its three primary metabolites in human plasma by LC-MS/MS

Shah, Priyanka A.; Parekh, Jignesh M.; Shrivastav, Pranav S.

doi:10.1016/j.microc.2017.08.008

Cited by 10 publications

(6 citation statements)

References 27 publications

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“…The method validation was performed as per the USFDA guidelines [24] and was similar to our previous work [25] , [26] . The detailed procedures and their acceptance criteria are summarized in Supplementary material .…”

Section: Methodsmentioning

confidence: 99%

Quantitation of tadalafil in human plasma using a sensitive and rapid LC-MS/MS method for a bioequivalence study

Bhadoriya¹,

Dasandi²,

Parmar³

et al. 2018

Journal of Pharmaceutical Analysis

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A highly sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed for the determination of tadalafil (TAD) in human plasma. TAD and its deuterated internal standard (IS), tadalafil-d3, were extracted from 200 µL plasma using Phenomenex Strata-X-C 33 µ extraction cartridges. Chromatographic analysis was carried out on Synergi™ Hydro-RP C18 (100 mm × 4.6 mm, 4 µm) column with a mobile phase consisting of methanol and 10 mM ammonium formate, pH 4.0 (90:10, v/v), delivered at a flow rate of 0.9 mL/min. Quantitation of the protonated analyte was done on a triple quadrupole mass spectrometer using multiple reaction monitoring via electrospray ionization. The precursor to product ions transitions monitored for TAD and TAD-d3 were m/z 390.3 → 268.2 and m/z 393.1 → 271.2, respectively. The calibration curve was linear over the concentration range of 0.50–500 ng/mL with correlation coefficient, r2 ≥ 0.9994. Acceptable intra-batch and inter-batch precision (≤ 3.7%) and accuracy (97.8% to 104.1%) were obtained at five concentration levels. The recovery of TAD from spiked plasma was highly precise and quantitative (98.95% to 100.61%). Further, the effect of endogenous matrix components was minimal. TAD was found to be stable under different storage conditions in human plasma and also in whole blood samples. The validated method was successfully used to determine TAD plasma concentration in a bioequivalence study with 20 mg TAD tablets in 24 healthy volunteers. Method performance was evaluated by reanalyzing 115 study samples.

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Section: Methodsmentioning

confidence: 99%

Quantitation of tadalafil in human plasma using a sensitive and rapid LC-MS/MS method for a bioequivalence study

Bhadoriya¹,

Dasandi²,

Parmar³

et al. 2018

Journal of Pharmaceutical Analysis

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“…A full validation of the presented method was executed (European Medicines Agency, ; US Food and Drug Administration, ). Methods used were similar to the one described in one of our previous reports (Shah, Parekh, & Shrivastav, ). The detailed procedures are summarized in Supporting Information.…”

Section: Methodsmentioning

confidence: 99%

Quantification of metronidazole in healthy subjects' feces using an LC–MS/MS method

Vanol

Sanyal

Shah

et al. 2018

Biomedical Chromatography

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A highly selective and sensitive liquid chromatography-tandem mass spectrometry (LC MS/MS) method was developed for the quantification of metronidazole (MTZ) in human feces. The analyte was recovered from feces after liquid-liquid extraction with ethyl acetate and separated on Waters Symmetry® C (100 × 4.6 mm, 5μm) column using 0.1% formic acid in water and acetonitrile (40:60, v/v) as the mobile phase. A stable-deuterated internal standard metronidazole-d4 (MTZ-d4) was used in the study. Mass analysis was performed on a triple quadrupole mass spectrometer in the positive electrospray ionization mode. A linear response function of MTZ was established in the concentration range of 0.50-250 ng/g, based on dry mass. The mean extraction recovery of MTZ (97.28%) and MTZ-d4 (96.76%) from spiked feces samples was consistent at higher as well as lower concentrations. Post-column infusion analysis showed no ion-suppression/enhancement effects and the mean IS-normalized matrix factor ranged from 0.986 to 1.013. Spiked feces samples stored at -20 and - 70°C for long-term stability were stable for at least 3 months, while extracted samples (dry and wet extracts) were stable up to 24 h. The method was applied to determine MTZ in feces of 12 healthy Indian subjects.

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“…The method was validated, and the m/z was 166, 184 and 240 for the analyte and 185 and 349.2 for the IS, respectively [48]. Other LC-MS/MS methods for the quantification of BUP in human plasma [150][151][152][153][154][155][156][157] and serum samples [158] are reported in Table 2.…”

Section: Liquid Chromatography (Lc)mentioning

confidence: 99%

Review on analytical methods for quantification of ADHD drugs in human biological samples

Sundari¹,

Amuthalakshmi²,

Nalini³

2020

Reviews in Analytical Chemistry

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Attention deficit hyperactivity disorder (ADHD) is a common neuro-developmental disorder. The symptoms of ADHD include difficulty in attention, memory and impulse control. Many pharmaceutical formulations (stimulants and non-stimulants) are available on the market to treat ADHD symptoms. The most commonly used drugs for treatment are amphetamine, methylphenidate, atomoxetine, bupropion, guanfacine and clonidine. In the field of pharmaceuticals, bioanalysis is an important tool used for the quantification of drugs and their metabolites present in biological samples using various analytical methods. Although a number of analytical methods were reported for the quantification of these drugs in biological samples of experimental animals, due to species differences, it is important to develop analytical methods to quantify these drugs in human biological samples to aid forensic and pharmacokinetic studies. In this review, we compile the bio-analytical methods such as spectrophotometry, spectrofluorimetry, mass spectrometry, electrophoresis, liquid chromatography and gas chromatography used for the quantification of ADHD drugs in human biological samples such as blood, plasma, serum, oral fluids, sweat, hair and urine based on earlier published articles from various journals.

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Assessment of critical extraction and chromatographic parameters for the determination of bupropion and its three primary metabolites in human plasma by LC-MS/MS

Cited by 10 publications

References 27 publications

Quantitation of tadalafil in human plasma using a sensitive and rapid LC-MS/MS method for a bioequivalence study

Quantitation of tadalafil in human plasma using a sensitive and rapid LC-MS/MS method for a bioequivalence study

Quantification of metronidazole in healthy subjects' feces using an LC–MS/MS method

Review on analytical methods for quantification of ADHD drugs in human biological samples

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