Abstract
A new, rapid, and sensitive liquid chromatography-tandem mass spectrometry method is developed and validated to quantitate the sibutramine active metabolites mono desmethyl sibutramine (M1) and di-desmethyl sibutramine (M2) using imipramine as the internal standard in human plasma samples for routine bioequivalence studies. The method involves rapid solid-phase extraction from plasma, eliminating the drying and reconstitution steps. The analytes are chromatographed on a C8 reversed-phase chromatographic column and analyzed by mass spectrometry in the multiple reaction monitoring mode, which enables a quantitation limit at the sub-nanogram level. The method has a chromatographic run time of 2.8 min. The proposed method is validated with a linear range of 0.1-8.0 and 0.2-16.0 ng/mL for M1 and M2, respectively, with a correlation coefficient of regression > or = 0.9990. The method is sensitive and reproducible, having intra- and inter-assay precision at the lower limit of quantitation (0.1 ng/mL for M1 and 0.2 ng/mL for M2) < 10.0%. The overall recovery for M1 and M2 is 93.5% and 77.9%, respectively. The method has been applied to a bioequivalence clinical study with great success.
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