Simultaneous determination of a drug candidate and its metabolite in rat plasma samples using ultrafast monolithic column high‐performance liquid chromatography/tandem mass spectrometry

Hsieh, Yunsheng; Wang, Gangfeng; Wang, Yuguang; Chackalamannil, Samuel; Brisson, Jean-Marc; Ng, Kwokei; Korfmacher, Walter A.

doi:10.1002/rcm.648

Cited by 79 publications

(64 citation statements)

References 19 publications

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“…Overall, 768 protein-precipitated samples were analysed within 3 h and 45 min. Hsieh et al [52] described a similar method for the determination of a drug discovery compound and its metabolite in blood plasma using the same monolithic column and LC/MS/MS. Baseline separation of the two compounds was achieved with run times of 24 or 30 s under isocratic or gradient conditions.…”

Section: High Throughput Analysis Of Drugs and Metabolitesmentioning

confidence: 98%

Applications of silica‐based monolithic HPLC columns

Cabrera

2004

J of Separation Science

398

226

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The recent invention and successive commercial introduction of monolithic silica columns has motivated many scientists from both academia and industry to study their use in HPLC. The first paper on monolithic silica columns appeared in 1996. Currently about 200 papers have been published relating to applications and characterization of monolithic silica columns, including monolithic capillaries. This review attempts to give an overview covering various aspects of this new column type in the field of high throughput analysis of drugs and metabolites, chiral separations, analysis of pollutants and food-relevant compounds, as well as in bioanalytical separations such as in proteomics. Some of the applications are described in greater detail. The numerous publications dealing with the physicochemical and chromatographic characterization of monolithic silica columns are briefly summarized.

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Section: High Throughput Analysis Of Drugs and Metabolitesmentioning

confidence: 98%

Applications of silica‐based monolithic HPLC columns

Cabrera

2004

J of Separation Science

398

226

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“…Theophylline-2-13 C-1,3-15 N 2 was purchased from Cambridge Isotope Labs (Andover, MA, USA). Debrisoquin-13 C-15 N 2 hydrobromide salt and dapsone-d 4 were synthesized in our laboratory. These internal standards do not contain analytes of interest.…”

Section: Chemicals and Reagentsmentioning

confidence: 99%

Simultaneous determination of theophylline, tolbutamide, mephenytoin, debrisoquin, and dapsone in human plasma using high‐speed gradient liquid chromatography/tandem mass spectrometry on a silica‐based monolithic column

Chen

Junga

Jiang

et al. 2003

J of Separation Science

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Simultaneous determination of theophylline, tolbutamide, mephenytoin, debrisoquin, and dapsone in human plasma using high-speed gradient liquid chromatography/tandem mass spectrometry on a silica-based monolithic column Theophylline, tolbutamide, mephenytoin, debrisoquin, and dapsone are marker substrates for CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A4, respectively. A silica-based monolithic column (Chromolith SpeedROD RP-18e, 5064.6 mm) was used to separate these five marker substrates of cytochrome P450 within only 84 s. Linear gradient elution was from acetonitrile-water-formic acid (10 : 90 : 1, v/v/v) to acetonitrile-water-formic acid (90 : 10 : 1, v/v/v) in 1.4 min. The flow rate was 2.5 mL/ min. The retention time was 0.52 min for theophylline, 0.67 min for debrisoquin, 0.78 min for dapsone, 0.96 min for mephenytoin, and 1.13 min for tolbutamide. Detection was by tandem mass spectrometry using a PE Sciex API 3000 mass spectrometer with a Turbo-Ionspray source in positive mode. A simple protein precipitation method was used. This method was validated over the concentration range of 5 -2000 ng/mL based on the sample volume of 0.1 mL.

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“…The mesopores provide the surface area for achieving adequate capacity while the macropores allow high flow-rates because of higher porosity, resulting in reduced flow resistance. Monolithic columns have become increasingly popular for use in ultrafast bioanalysis of drug candidates using tandem mass spectrometric detection [61][62][63][64]. (Fig.…”

Section: Chromatographymentioning

confidence: 99%

Critical Review of Development, Validation, and Transfer for High Throughput Bioanalytical LC-MS/MS Methods

Zhou¹,

Song²,

Tang³

et al. 2005

CPA

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Swift growth in the use of LC-MS/MS for the analysis of drugs in biological matrices has been compelled by the need for timely and high-quality data at many stages in drug discovery and development process: from high throughput screening of drug candidates and rapid data generation for pre-clinical studies to almost 'real-time' analysis of clinical samples. Prompt and rational method development, validation, and transfer play a pivotal role in achieving the goals of "faster, better, and cheaper" for pharmacokinetic studies since this could easily account for more than 50% of the time and labor resources for a moderate-sized project. Strategy for rational method development, validation and transfer has been largely kept as institutional knowledge but rarely appeared in literature. In this review article, strategies for developing and validating robust high throughput LC-MS/MS methods will be critically reviewed and discussed. Automated sample preparation, fast chromatography, minimization of matrix effects, and strategy of narrowing the gap between validation and incurred sample analysis are just a few topics covered in this review. Other interesting approaches for improving method efficiency and ruggedness such as direct injection SPE and liquid/liquid extracts as well as multiplexing of LC columns will also be discussed. Potential pitfalls during method development and validation are pointed out. At the end, the question "how fast is fast enough and how fast is too fast?" will be answered after considering all aspects of the method development and validation.

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Simultaneous determination of a drug candidate and its metabolite in rat plasma samples using ultrafast monolithic column high‐performance liquid chromatography/tandem mass spectrometry

Cited by 79 publications

References 19 publications

Applications of silica‐based monolithic HPLC columns

Applications of silica‐based monolithic HPLC columns

Simultaneous determination of theophylline, tolbutamide, mephenytoin, debrisoquin, and dapsone in human plasma using high‐speed gradient liquid chromatography/tandem mass spectrometry on a silica‐based monolithic column

Critical Review of Development, Validation, and Transfer for High Throughput Bioanalytical LC-MS/MS Methods

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