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A rapid and sensitive high-performance liquid chromatography–mass spectrometry method was developed and validated to determine 4-fluoroaniline concentration in ezetimibe. Chromatographic separation was achieved on a Phenomenex Gemini-NX C18 column (150 × 4.6 mm, 3 μm) maintained at 30°C. The liquid chromatography system was operated in gradient mode with an injection volume of 20 μL at a flow rate of 1 mL/min. Mobile phase A was water and mobile phase B consisted of acetonitrile with 0.05% acetic acid. The detection was performed using a single quadrupole mass spectrometer in single ion monitoring mode by using positive ionization. An  m / z  value of 112 was selected for monitoring 4-fluoroaniline. The method showed good linearity over the concentration range of 0.94–30.26 ng/mL. The limit of quantification and limit of detection were 0.19 and 0.94 ng/mL, respectively. The precision relative standard deviations were less than 8.7% ( n  = 12), and the accuracy values were within 92–99%. A standard solution of 4-fluoroaniline was stable for at least 24 h at 25°C. Small changes in the organic phase acidity of the mobile phase, flow rate, column temperature, and the instrument parameters had no significant effect on the results for 4-fluoroaniline.

Development of an LC–MS Method for 4-Fluoroaniline Determination in Ezetimibe