Development and validation of gas chromatography-mass spectroscopy method for determination of prilocaine HCl in human plasma using internal standard methodology.

Abstract

The accurate determination of prilocaine HCl levels in plasma is important in both clinical and pharmacological/toxicological studies. Prilocaine HCl is quickly hydrolyzed to o-toluidine, causing methemoglobinemia. For this, the present work describes the methodology and validation of a GC-MS assay for determination of prilocaine HCl with lidocaine HCl as internal standard in plasma. The validation parameters of linearity, precision, accuracy, recovery, specificity, limit of detection and limit of quantification were studied. The range of quantification for the GC-MS was 20-250 ng/mL in plasma. Within-day and between-day precision, expressed as the relative standard deviation (RSD) were less than 6.0%, and accuracy (relative error) was better than 9.0% (n = 6). The analytical recovery of prilocaine HCl and IS from plasma has averaged 94.79 and 96.8%, respectively. LOQ and LOD values for plasma were found to be 20 and 10 ng/mL, respectively. The GC-MS method can be used for determination from plasma of prilocaine HCl in routine measurement as well as in pharmacokinetic studies for clinical use.

• Authors: Yucel Kadioglu, Alptug Atila
• Journal: Biomedical chromatography : BMC (Biomed Chromatogr) Vol. 21 Issue 10 Pg. 1077-82 (Oct 2007) ISSN: 0269-3879 [Print] England
• PMID: 17583875 (Publication Type: Evaluation Study, Journal Article, Research Support, Non-U.S. Gov't, Validation Study)
• Copyright: 2007 John Wiley & Sons, Ltd

Chemical References

• Anesthetics, Local
• Prilocaine
• Lidocaine

Topics

• Anesthetics, Local (blood)
• Calibration
• Chemical Fractionation
• Gas Chromatography-Mass Spectrometry (methods)
• Humans
• Lidocaine (blood, standards)
• Prilocaine (blood)
• Reference Standards
• Reproducibility of Results
• Sensitivity and Specificity