Determination of Carbocysteine from Human Plasma

Maynard, William R.; Bruce, Robert; Fox, Genevieve G.

doi:10.1002/jps.2600671232

Cited by 17 publications

(6 citation statements)

References 10 publications

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“…There was no significant difference between the two formulations with regard to the pharmacokinetic parameters including C max , AUC 0 − t , and AUC 0 → ∞ . In the current study, C max values for both formulations ranged from 5.6–5.8 µg/mL after a single dose of 1000 mg carbocysteine, which were slightly lower than those reported in the literature 1, 5, 23, 24. The values of T max obtained in the current study were in agreement with reported values 1, 5, 23, 24…”

Section: Resultssupporting

confidence: 90%

“…The retention time for carbocysteine was 0.95 min. The method had the shortest total running time (2.0 min) for determination of carbocysteine in human plasma compared with those reported in the literature 4–17…”

Section: Resultsmentioning

confidence: 88%

“…For the lack of absorption in the visible and UV ranges, various analytical methods reported for the measurement of carbocysteine in biomatrix reply on the detection of UV‐active, fluorescent functional or volatile derivatives. These methods include gas chromatographic methods with prior derivatization with heptafluorobutyric anhydride or acetic anhydride,4, 5 ion‐exchange chromatography following derivatization prior to UV detection,6, 7 high‐performance liquid chromatography (HPLC) with pre‐column derivatization (with phenyl isothiocyanate,8, 9 o ‐phthalaldehyde,10–12 dabsyl chloride,13, 14 and 9‐fluorenylmethyl chloroformate using fluorescent pre‐column labeling15), and liquid chromatography/tandem mass spectrometry (LC/MS/MS) with atmospheric‐pressure chemical ionization (APCI) employing precolumn derivatization 16. These methods often suffered from a very complicated and time‐consuming derivatization procedure before analysis.…”

mentioning

confidence: 99%

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High‐throughput determination of carbocysteine in human plasma by liquid chromatography/tandem mass spectrometry: application to a bioequivalence study of two formulations in healthy volunteers

Zhao

Zhong

et al. 2006

Rapid Comm Mass Spectrometry

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A rapid and sensitive liquid chromatography/tandem mass spectrometry (LC/MS/MS) method to determine carbocysteine in human plasma was developed and fully validated. After methanol-induced protein precipitation of the plasma samples, carbocysteine was subjected to LC/MS/MS analysis using electrospray ionization (ESI). The MS system was operated in the selected ion monitoring (SRM) mode. Chromatographic separation was performed on a Hypurity C18 column (i.d. 2.1 mm x 50 mm, particle size 5 microm). The method had a chromatographic running time of 2.0 min and linear calibration curves over the concentration ranges of 0.1-20 microg/mL for carbocysteine. The lower limit of quantification (LLOQ) of the method was 0.1 microg/mL for carbocysteine. The intra- and inter-day precision was less than 7% for all quality control samples at concentrations of 0.5, 2.0, and 10.0 microg/mL. These results indicate that the method was efficient with a simple preparation procedure and a very short running time (2.0 min) for carbocysteine compared with methods reported in the literature and had high selectivity, acceptable accuracy, precision and sensitivity. The validated LC/MS/MS method has been successfully used to a bioequivalence study of two tablet formulations of carbocysteine in healthy volunteers.

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Section: Resultssupporting

confidence: 90%

Section: Resultsmentioning

confidence: 88%

mentioning

confidence: 99%

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High‐throughput determination of carbocysteine in human plasma by liquid chromatography/tandem mass spectrometry: application to a bioequivalence study of two formulations in healthy volunteers

Zhao

Zhong

et al. 2006

Rapid Comm Mass Spectrometry

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“…Two gas chromatographic methods have also been developed for the quantiÐcation of SCMC either in human urine, by derivatization with heptaÑuorobutyric anhydride,12 or in human plasma, after N-acylation with acetic anhydride and esteriÐcation with diazomethane. 13 Recently, capillary zone electrophoresis (CZE) has been used to determine SCMC and some of its metabolites in human urine, without prior derivatization.14 This method uses on-column UV (206 nm) detection, but it has insufficient sensitivity (30 lg ml~1) to be usable for pharmacokinetic monitoring.…”

Section: Figure 1 Structures Of S -Carboxymethyl-(r )-Cysteine (Scmcmentioning

confidence: 99%

Quantification ofS-Carboxymethyl-(R)-Cysteine in Human Plasma by High-performance Ion-exchange Liquid Chromatography/Atmospheric Pressure Ionization Mass Spectrometry

Anacardio¹,

Cantalini²,

Angelis³

et al. 1997

J. Mass Spectrom.

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The determination of S‐carboxymethyl‐(R)‐cysteine (SCMC) in human plasma during extended bioequivalence studies demands a rapid, accurate and selective assay technique. A liquid chromatographic/mass spectrometric method was developed which involves rough protein precipitation followed by high‐performance liquid chromatographic separation with an ion‐exchange column and atmospheric pressure ionization (API) mass spectrometric detection, with the instrument operating with electrospray ionization (ESI) and in the selected‐ion monitoring mode. The drug and the internal standard S‐[(R)‐1‐carboxyethyl]‐(R)‐cysteine (SCEC) are detected by focusing the first quadrupole of the triple stage system on MH+ ions, thus permitting elimination of endogenous interfering substances and allowing a detection limit of 0.05 μg ml‐1. The chromatographic run time is 16 min and the method has sufficient sensitivity, precision, accuracy and selectivity for routine analyses of clinical plasma samples containing SCMC at concentrations in the range 0.2–20 μg ml‐1. In summary, this LC/MS‐based assay of SCMC demonstrates advantages of easy sample preparation, low limit of quantification (200 ng per ml of human plasma) without any derivatization step, high specificity and rapid sample analysis with an overall throughput of more than 60 analyses per day. © 1997 by John Wiley & Sons, Ltd.

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“…A gas chromatographic method has also been developed for the quantification of SCMC in human plasma after N-acylation with acetic anhydride and esterification with diazomethane. 11 A capillary zone electrophoresis (CZE) with on-column UV (206 nm) detection has been used to determine SCMC and some of its metabolites in human urine, without prior derivatization, 12 but it had insufficient sensitivity (30 µg/ml) to be usable for pharmacokinetic monitoring. Anacardio et al 13 developed a high-performance ion-exchange liquid chromatographyatmospheric pressure ionization mass spectrometry (LC-APCI/MS) method for the analysis SCMC in human plasma without any derivatization step, which required a long chromatographic separation time.…”

Section: Introductionmentioning

confidence: 99%

Quantification of fudosteine in human plasma by high‐performance liquid chromatography‐electrospray ionization mass spectrometry employing precolumn derivatization with 9‐fluorenylmethyl chloroformate

Zhang

Jiao

et al. 2006

J. Mass Spectrom.

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This paper describes a novel method for the sensitive and selective determination of fudosteine in human plasma. The method involves a derivatization step with 9-fluorenylmethyl chloroformate (FMOC-Cl) in borate buffer and detection based on high-performance liquid chromatography-electrospray ionization mass spectrometry (LC/ESI/MS). After acetonitrile-induced protein precipitation of plasma samples, fudosteine was derivatized with FMOC-Cl, then extracted by ethyl acetate, evaporated, reconstituted and injected using an LC/ESI/MS instrument. Separation was achieved using an ODS column and isocratic elution. Excellent linearity was obtained for the entire calibration range from 0.05 to 20 microg/ml. Validation assays of the lower limit of quantification (LLOQ) as well as for the intra- and inter-batch precision and accuracy met the international acceptance criteria for bioanalytical method validation. Using the developed analytical method, fudosteine could be detected for the first time in human plasma with a low limit of detection (LLOD) of 0.03 microg/ml. The proposed method has been successfully applied to study the pharmacokinetics of fudosteine in healthy Chinese volunteers after single and multiple oral administration.

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Determination of Carbocysteine from Human Plasma

Cited by 17 publications

References 10 publications

High‐throughput determination of carbocysteine in human plasma by liquid chromatography/tandem mass spectrometry: application to a bioequivalence study of two formulations in healthy volunteers

High‐throughput determination of carbocysteine in human plasma by liquid chromatography/tandem mass spectrometry: application to a bioequivalence study of two formulations in healthy volunteers

Quantification ofS-Carboxymethyl-(R)-Cysteine in Human Plasma by High-performance Ion-exchange Liquid Chromatography/Atmospheric Pressure Ionization Mass Spectrometry

Quantification of fudosteine in human plasma by high‐performance liquid chromatography‐electrospray ionization mass spectrometry employing precolumn derivatization with 9‐fluorenylmethyl chloroformate

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