LC-MS-MS Separation and Simultaneous Determination of Tolterodine and its Active Metabolite, 5-Hydroxymethyl Tolterodine in Human Plasma
2010
Yadav, Manish | Upadhyay, Vivek | Chauhan, Vipul | Solanki, Gajendra | Jani, Alpa | Baxi, Girin A | Singhal, Puran | Shrivastav, Pranav S
A selective, sensitive and high throughput LC-MS-MS method has been developed and validated for the chromatographic separation and quantitation of tolterodine (TOL) and its metabolite 5-hydroxymethyl TOL in human plasma. Sample clean-up concerned liquid-liquid extraction of the drug, metabolite and their respective labelled internal standards from 300 μL human plasma. Both the analytes were chromatographically separated on a Symmetry C18 (100 mm × 4.6 mm, 5 μm particle size) analytical column using 10 mM ammonium formate (pH 5.0 ± 0.1, adjusted with formic acid) and acetonitrile (35:65, v/v) as the mobile phase with a resolution factor of 2.72. The method was validated over the concentration range of 0.025-10.0 ng mL⁻¹ for both analytes. The process efficiency found for TOL and its metabolite was 98.3 and 99.5%, respectively. The method was successfully applied to a pivotal bioequivalence study in 41 healthy human subjects after oral administration of a 2 mg tablet formulation under fasting conditions.
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