Mistri HN, Jangid AG, Pudage A, Shrivastav P
HPLC-ESI-MS/MS validated method for simultaneous quantification of zopiclone and its metabolites, N-desmethyl zopiclone and zopiclone-N-oxide in human plasma. [JOURNAL ARTICLE]
J Chromatogr B Analyt Technol Biomed Life Sci 2008 Feb 17.
A simple, selective and sensitive isocratic HPLC method with triple quadrupole mass spectrometry detection has been developed and validated for simultaneous quantification of zopiclone and its metabolites in human plasma. The analytes were extracted using solid phase extraction, separated on Symmetry shield RP8 column (150mmx4.6mm i.d., 3.5mum particle size) and detected by tandem mass spectrometry with a turbo ion spray interface. Metaxalone was used as an internal standard. The method had a chromatographic run time of 4.5min and linear calibration curves over the concentration range of 0.5-150ng/mL for both zopiclone and N-desmethyl zopiclone and 1-150ng/mL for zopiclone-N-oxide. The intra-batch and inter-batch accuracy and precision evaluated at lower limit of quantification and quality control levels were within 89.5-109.1% and 3.0-14.7%, respectively, for all the analytes. The recoveries calculated for the analytes and internal standard were >/=90% from spiked plasma samples. The validated method was successfully employed for a comparative bioavailability study after oral administration of 7.5mg zopiclone (test and reference) to 16 healthy volunteers under fasted condition.
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