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Development of a high pressure liquid chromatography method for the determination of mycophenolic acid and its glucuronide metabolite in small volumes of plasma from paediatric patients.
J Pharm Biomed Anal. 2004 Apr 01; 35(1):87-92.JP

Abstract

In order to facilitate the simultaneous determination of the levels of mycophenolic acid (MPA) and mycophenolic acid glucuronide (MPAG) in plasma samples a step wise gradient high performance liquid chromatography (HPLC) method was developed using UV detection system and naproxen as an internal standard. The analytes were extracted from plasma using Strata-X polymeric solid phase extraction (SPE) cartridges. Separation was achieved within a total chromatographic run time of 18 min at 1.0 ml/min flow rate using a Hv PURITY C18 column. The method was found to be linear over the concentration range investigated, 1.0-16 microg/ml (r > 0.99) for MPA and 10-160 microg/ml (r > 0.99) for MPAG. The limit of detection was 0.1 microg/ml for both MPAG and MPA. The intra- and inter-day imprecisions expressed as R.S.D. were 7.8 and 6.6%, respectively, for MPA (1 microg/ml) and 6.2% and 5.6%, respectively, for MPAG (20 microg/ml). The average extraction recovery from plasma was 93.06%, for MPA and 92.41% for MPAG. The method developed was found to be accurate and precise in quantifying the level of MPA and MPAG over a their therapeutic range of concentrations in small volumes of plasma and thus can be effectively used in the routine drug monitoring procedures and pharmacokinetic studies. It was also developed in such a way that it should be easily coupled to an electro-spray ionization mass spectrometer should greater sensitivity be required.

Authors+Show Affiliations

Watson DG
Department of Pharmaceutical Sciences, Strathclyde Institute of Biomedical Science (SIBS), University of Strathclyde, 27 Taylor Street, Glasgow G4 0NR, UK. d.g.watson@strath.ac.uk
Araya FG
No affiliation info available
Galloway PJ
No affiliation info available
Beattie TJ
No affiliation info available

MeSH

CalibrationChildChromatography, High Pressure LiquidGlucuronatesGlucuronidesHumansMycophenolic AcidReference StandardsSensitivity and SpecificityTime Factors

Pub Type(s)

Journal Article

Language

eng

PubMed ID

15030883

Citation

Watson, D G., et al. "Development of a High Pressure Liquid Chromatography Method for the Determination of Mycophenolic Acid and Its Glucuronide Metabolite in Small Volumes of Plasma From Paediatric Patients." Journal of Pharmaceutical and Biomedical Analysis, vol. 35, no. 1, 2004, pp. 87-92.
Watson DG, Araya FG, Galloway PJ, et al. Development of a high pressure liquid chromatography method for the determination of mycophenolic acid and its glucuronide metabolite in small volumes of plasma from paediatric patients. J Pharm Biomed Anal. 2004;35(1):87-92.
Watson, D. G., Araya, F. G., Galloway, P. J., & Beattie, T. J. (2004). Development of a high pressure liquid chromatography method for the determination of mycophenolic acid and its glucuronide metabolite in small volumes of plasma from paediatric patients. Journal of Pharmaceutical and Biomedical Analysis, 35(1), 87-92.
Watson DG, et al. Development of a High Pressure Liquid Chromatography Method for the Determination of Mycophenolic Acid and Its Glucuronide Metabolite in Small Volumes of Plasma From Paediatric Patients. J Pharm Biomed Anal. 2004 Apr 1;35(1):87-92. PubMed PMID: 15030883.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development of a high pressure liquid chromatography method for the determination of mycophenolic acid and its glucuronide metabolite in small volumes of plasma from paediatric patients. AU - Watson,D G, AU - Araya,F G, AU - Galloway,P J, AU - Beattie,T J, PY - 2003/10/28/received PY - 2003/11/12/revised PY - 2003/12/14/accepted PY - 2004/3/20/pubmed PY - 2004/10/27/medline PY - 2004/3/20/entrez SP - 87 EP - 92 JF - Journal of pharmaceutical and biomedical analysis JO - J Pharm Biomed Anal VL - 35 IS - 1 N2 - In order to facilitate the simultaneous determination of the levels of mycophenolic acid (MPA) and mycophenolic acid glucuronide (MPAG) in plasma samples a step wise gradient high performance liquid chromatography (HPLC) method was developed using UV detection system and naproxen as an internal standard. The analytes were extracted from plasma using Strata-X polymeric solid phase extraction (SPE) cartridges. Separation was achieved within a total chromatographic run time of 18 min at 1.0 ml/min flow rate using a Hv PURITY C18 column. The method was found to be linear over the concentration range investigated, 1.0-16 microg/ml (r > 0.99) for MPA and 10-160 microg/ml (r > 0.99) for MPAG. The limit of detection was 0.1 microg/ml for both MPAG and MPA. The intra- and inter-day imprecisions expressed as R.S.D. were 7.8 and 6.6%, respectively, for MPA (1 microg/ml) and 6.2% and 5.6%, respectively, for MPAG (20 microg/ml). The average extraction recovery from plasma was 93.06%, for MPA and 92.41% for MPAG. The method developed was found to be accurate and precise in quantifying the level of MPA and MPAG over a their therapeutic range of concentrations in small volumes of plasma and thus can be effectively used in the routine drug monitoring procedures and pharmacokinetic studies. It was also developed in such a way that it should be easily coupled to an electro-spray ionization mass spectrometer should greater sensitivity be required. SN - 0731-7085 UR - https://www.unboundmedicine.com/medline/citation/15030883/Development_of_a_high_pressure_liquid_chromatography_method_for_the_determination_of_mycophenolic_acid_and_its_glucuronide_metabolite_in_small_volumes_of_plasma_from_paediatric_patients_ DB - PRIME DP - Unbound Medicine ER -
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