فهرست نشریات علمی دسترسی آزاد ایران

A sensitive and selective LC-MS/MS method was developed and validated for the quantification of Alogliptin in human plasma using solid-phase extraction (SPE). The method utilized a SCIEX Triple Quad 4500 mass spectrometer in positive electrospray ionization mode with multiple reaction monitoring (MRM) transitions of m/z 340.2/116.0 for Alogliptin and m/z 344.2/116.0 for the internal standard, Alogliptin 13C D3. Chromatographic separation was achieved on a Phenomenex Gemini® C18 column (100 × 4.6 mm, 5 µm) using an isocratic mobile phase of acetonitrile and 0.1% formic acid (30:70, v/v) at a flow rate of 0.6 mL/min. The method demonstrated excellent linearity over a concentration range of 1.009 to 400.321 ng/mL with r² > 0.99. Validation studies confirmed system suitability, selectivity, precision, accuracy, recovery, matrix effect, dilution integrity, ruggedness, and stability under various conditions. The method yielded consistent recoveries of 95.8–99.7% for the analyte and 103.1–107.0% for the internal standard. No significant autosampler carryover or interference was observed. The developed method is suitable for bioanalytical applications, including pharmacokinetic and clinical studies of Alogliptin.