Abstract
A simple, sensitive, and selective LC-MS/MS method was developed and validated for the quantification of carbocisteine in human plasma. Rosiglitazone was used as the internal standard and heparin was used as the anticoagulant. The chromatographic separation was performed by using the Waters Symmetry Shield RP 8, 150 × 3.9 mm, 5 μ column at 40°C with a mobile phase consisting of a mixture of methanol and 0.5% formic acid solution in a 40:60 proportion. The flow rate was 500 μl/min along with a 5 μl injection volume. Protein precipitation was used as the extraction method. Mass spectrometric data were detected in positive ion mode. The MRM mode of the ions for carbocisteine was 180.0 > 89.0 and for rosiglitazone it was 238.1 > 135.1. The method was validated in the concentration curve range of 50.000 ng/mL to 6000.000 ng/mL. The retention times of carbocisteine and the internal standard rosiglitazone were approximately 2.20 and 3.01 min, respectively. The overall run time was 4.50 min. This method was found suitable to analyze human plasma samples for the application in pharmacokinetic and BA/BE studies.
Highlights
Blank human plasma containing heparin and ethylenediaminetetraacetic acid (EDTA) were extracted and analysed to determine the extent to which endogenous human plasma components may contribute to chromatographic interference with the analyte or the internal standard
No significant interferences were observed in eight different lots of human heparin plasma samples and two lots of human EDTA plasma samples
MRM chromatograms of carbocisteine and rosiglitazone in (A) human blank plasma; (B) human plasma spiked with internal standard (IS); (C) an lower limit of quantification (LLOQ) sample along with IS
Summary
© Dhanure et al.; licensee Österreichische Apotheker-Verlagsgesellschaft m.
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