A rapid and sensitive liquid chromatography tandem mass spectrometry method has been developed and validated for the determination of Quetiapine in human K2EDTA plasma with mass spectrometry (MS) detection. Clozapine was employed as an internal standard. Samples were extracted using Solid Phase Extraction (SPE). In this study the samples were prepared using the eluent taken directly from the SPE without evaporation, as the sensitivity recovery and reproducibility are less in Liquid Extraction (LE) and eluent evaporation after processing through the SPE when compared to the eluent without evaporation. DVB-LP polymeric SPE cartridges (30mg,1ml capacity) were used for sample processing and the concentration of Quetiapine was determined by isocratic HPLC-MS/MS. Chromatography was performed on a Inertsil ODS, 50×4.6mm, 3µm C18 column, with the mobile phase consisting of 10mM Ammonium acetate, acetonitrile and methanol (10:25:65) followed by detection using mass spectrometry. The MRM mode was used for MS/MS detection. The method was validated over a concentration range of 5ng/mL to 1000ng/mL. The mean recovery of Quetiapine is 72.23 % at an overall precision of 16.74 %, with lower limit of quantification set at 5ng/mL. Linearity was established for concentrations in range of 5ng/mL to 1000ng/mL, with a Correlation coefficient (r) were found to be more than 0.99. The developed method is useful in the Pharmacokinetic study of Quetiapine and conducting the Bioavailability and Bioequivalence studies during the development of Generic Drug Products.
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