Abstract
A simple, fast, sensitive, and specific liquid chromatography–tandem mass spectrometry (LC-MS/MS) method for the analysis of fesoterodine (FESO) in pharmaceutical formulations was developed and validated using manidipine as internal standard (IS). The LC-MS/MS method was carried out on a Luna C8(2) column (50 mm × 3.0 mm i.d., 3 μm) with a mobile-phase consisting of methanol/0.1% formic acid (90:10, v/v). The mass spectrometry method was performed employing a positive electrospray ionization technique, operating in multiple reaction monitoring mode (MRM), monitoring the transitions of 412.2 → 223.0 and 611.1 → 167.0 for FESO and IS, respectively. The total analysis time was 2 min and it was linear in the concentration range of 5–1000 ng mL−1. Placebo solution and mobile-phase components were evaluated on the specificity test and did not interfere with the analyte or the IS. Intra-day and inter-day precision and accuracy evaluated by RSDs and relative errors, respectively, were lower than 5% for all analytes. The method proved to be robust by a fractional factorial design evaluation. The proposed method was successfully applied for the quantitative analysis of FESO in tablet formulations to support the quality control.
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