Dilemma with Matrix Effect in Bioanalysis – Perspectives from Bioavailability/Bioequivalence Studies for Product Registration?

Nr, Srinivas

doi:10.1055/s-0033-1358729

Cited by 3 publications

(2 citation statements)

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“…Matrix effects in LC‐MS cannot be entirely eliminated in bioanalysis (Srinivas, ), but some methods and some adequate strategies can be selected in order to minimize or control them. In practice, one or a combination of strategies is selected in order to have a minimum influence of matrix on the MS analytical signal of target analytes (Matuszewski, Constanzer, & Chavez‐Eng, ).…”

Section: Matrix Effect and Sample Preparationmentioning

confidence: 99%

“…According to this equation, a value of ME = 0% means that no matrix effect is observed in signal measuring, while negative values represent suppressions of the analyte signal, and positive values stand for enhancements induced by matrix (Stahnke, Kittlaus, Kempe, & Alder, 2012). ME can also be estimated by the following formula: Matrix effects in LC-MS cannot be entirely eliminated in bioanalysis (Srinivas, 2014), but some methods and some adequate strategies can be selected in order to minimize or control them. In practice, one or a combination of strategies is selected in order to have a minimum influence of matrix on the MS analytical signal of target analytes (Matuszewski, Constanzer, & Chavez-Eng, 2003).…”

Section: Matrix Effect and Sample Preparationmentioning

confidence: 99%

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Sample preparation for large‐scale bioanalytical studies based on liquid chromatographic techniques

Medvedovici

Bacalum

David

2017

Biomedical Chromatography

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Quality of the analytical data obtained for large-scale and long term bioanalytical studies based on liquid chromatography depends on a number of experimental factors including the choice of sample preparation method. This review discusses this tedious part of bioanalytical studies, applied to large-scale samples and using liquid chromatography coupled with different detector types as core analytical technique. The main sample preparation methods included in this paper are protein precipitation, liquid-liquid extraction, solid-phase extraction, derivatization and their versions. They are discussed by analytical performances, fields of applications, advantages and disadvantages. The cited literature covers mainly the analytical achievements during the last decade, although several previous papers became more valuable in time and they are included in this review.

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Section: Matrix Effect and Sample Preparationmentioning

confidence: 99%

Section: Matrix Effect and Sample Preparationmentioning

confidence: 99%

Sample preparation for large‐scale bioanalytical studies based on liquid chromatographic techniques

Medvedovici

Bacalum

David

2017

Biomedical Chromatography

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Chromatography as a Core Step for an Analytical Procedure

Moldoveanu

David²

2015

Modern Sample Preparation for Chromatography

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HPLC–MS-MS Method Development and Validation of Antileishmanial Agent, S010-0269, in Hamster Serum

et al. 2015

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A rapid, sensitive and simple high-performance liquid chromatography-tandem mass spectrometry method was developed and validated for the quantification of the antileishmanial agent, S010-0269, in hamster serum. A Discovery HS C-18 column (5 μm, 50 × 4.6 mm) maintained at 40°C was utilized for chromatographic separation with mobile phase [acetonitrile: aqueous ammonium acetate (0.01 M) buffer (85:15, v/v)] at a flow rate of 0.6 mL/min. The method requires low serum volume (20 µL) with a run time of 3.5 min. Excellent linear relationships (r ≥ 0.99) were obtained between the measured and added concentration over a range of 1-200 ng/mL. Validation parameters (accuracy, specificity, precision, recovery, matrix effect and stability) were assessed as per FDA guidelines. The precision and accuracy were acceptable as indicated by relative standard deviation ranging from 2.3 to 13.6% and bias values ranging from 1.5 to 6.5%, respectively. Moreover, the compound was found stable in hamster serum even after 30 days of storage at -80°C and being subjected to two freeze-thaw cycles. The validated method was successfully applied to the pharmacokinetic study after 10 mg/kg oral dose of S010-0269 in hamsters.

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Dilemma with Matrix Effect in Bioanalysis – Perspectives from Bioavailability/Bioequivalence Studies for Product Registration?

Cited by 3 publications

References 0 publications

Sample preparation for large‐scale bioanalytical studies based on liquid chromatographic techniques

Sample preparation for large‐scale bioanalytical studies based on liquid chromatographic techniques

Chromatography as a Core Step for an Analytical Procedure

HPLC–MS-MS Method Development and Validation of Antileishmanial Agent, S010-0269, in Hamster Serum

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