Rapid and simultaneous quantification of a mixture of biopharmaceuticals by a liquid chromatography/quadrupole time‐of‐flight mass spectrometric method in rat plasma following cassette‐dosing

Park, Min‐Ho; Byeon, Jin‐Ju; Shin, Seok‐Ho; Kim, Nahye; Park, Yuri; Lee, Byeong Ill; Choi, Jangmi; Shin, Young Geun

doi:10.1002/rcm.8123

Cited by 2 publications

(1 citation statement)

References 23 publications

(33 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The method validation was carried out in accordance with Food and Drug Administration (FDA) regulations for the validation of bioanalytical methods [ 27 ].…”

Section: Resultsmentioning

confidence: 99%

A Novel Method for the Determination of Vancomycin in Serum by High-Performance Liquid Chromatography-Tandem Mass Spectrometry and Its Application in Patients with Diabetic Foot Infections

Liu

Zhang

2018

Molecules

View full text Add to dashboard Cite

A novel, precise, and accurate high-performance liquid chromatography-tandem mass spectrometry (Q-trap-MS) method was developed, optimized, and validated for determination of vancomycin in human serum using norvancomycin as an internal standard. Effect of different parameters on the analysis was evaluated. ZORBAX SB-C18 column (150 × 4.6 mm, 5 μm) using water (containing 0.1% formic acid, v/v)–acetonitrile (containing 0.1% formic acid, v/v) as a mobile phase was chosen. The calibration curve was linear over the concentration ranges of 1 to 2000 ng/mL for vancomycin. The limit of detection (LOD) and limit of quantification (LOQ) for vancomycin were 0.3 and 1.0 ng/mL. Recoveries were between 87.2 and 102.3%, which gave satisfactory precision. A total of 100 serum samples (from 50 patients with diabetic foot proven Gram-positive infection and 50 nondiabetic patients with pneumonia requiring hospitalization and antibiotic therapy) were analyzed by this method. The trough vancomycin concentrations of diabetic foot infection (DFI) patients and nondiabetic patients were 8.20 ± 2.83 μg/mL (range: 4.80–14.2 μg/mL) and 15.80 ± 5.43 μg/mL (range: 8.60–19.5 μg/mL), respectively. The method is sensitive, precise, and reproducible, it could be applied for routine laboratory analysis of vancomycin in serum samples.

show abstract

“…The method validation was carried out in accordance with Food and Drug Administration (FDA) regulations for the validation of bioanalytical methods [ 27 ].…”

Section: Resultsmentioning

confidence: 99%

A Novel Method for the Determination of Vancomycin in Serum by High-Performance Liquid Chromatography-Tandem Mass Spectrometry and Its Application in Patients with Diabetic Foot Infections

Liu

Zhang

2018

Molecules

View full text Add to dashboard Cite

show abstract

Quantification of Surrogate Monoclonal Antibodies in Mouse Serum Using LC–MS/MS

et al. 2021

View full text Add to dashboard Cite

Background: Surrogate monoclonal antibodies (mAbs) used in preclinical in vivo studies can be challenging to quantify due to lack of suitable immunoaffinity reagents or unavailability of the mAb protein sequence. Generic immunoaffinity reagents were evaluated to develop sensitive LC–MS/MS assays. Peptides of unknown sequence can be used for selective LC–MS quantification. Results: anti-mouse IgG1 was found to be an effective immunoaffinity reagent, enabling quantification of mouse IgG1 mAbs in mouse serum. Selective peptides of unknown sequence were applied for multiplex LC–MS quantification of two rat mAbs co-dosed in mouse. Conclusion: Generic anti-mouse IgG subtype-specific antibodies can be used to improve assay sensitivity and peptides of unknown sequence can be used to quantify surrogate mAbs when the mAb protein sequence in unavailable.

show abstract

Rapid and simultaneous quantification of a mixture of biopharmaceuticals by a liquid chromatography/quadrupole time‐of‐flight mass spectrometric method in rat plasma following cassette‐dosing

Abstract: These findings suggest that the cassette-dosing approach could be used to evaluate the PK properties of biopharmaceuticals in the early drug discovery stage. Also, this method would be useful for other preclinical sample analysis without developing new reagents for sample preparation.

Cited by 2 publications

References 23 publications

A Novel Method for the Determination of Vancomycin in Serum by High-Performance Liquid Chromatography-Tandem Mass Spectrometry and Its Application in Patients with Diabetic Foot Infections

A Novel Method for the Determination of Vancomycin in Serum by High-Performance Liquid Chromatography-Tandem Mass Spectrometry and Its Application in Patients with Diabetic Foot Infections

Quantification of Surrogate Monoclonal Antibodies in Mouse Serum Using LC–MS/MS

Contact Info

Product

Resources

About