The ultra-performance liquid chromatography determination of domperidone and its process-related impurities.

Abstract

A rapid ultra-performance liquid chromatography (UPLC) method for the determination of domperidone in the presence of its process impurities and droperidol was developed and validated. The rapid chromatographic separation was achieved using a sub 2 µm Hypersil Zorbax eXtra Densely Bonded C18 column (30 × 4.6 mm, i.d., 1.8 µm). A gradient mobile phase consisting of Solvent A: 0.06 M ammonium acetate and Solvent B: methanol, with a flow rate of 1 mL/min was employed. The column temperature was set at 40°C, and the diode-array detector was set at 280 nm. An injection volume of 3 µL was used. The currently utilized European Pharmacopeia (Eur. Pharm.) method employed by Janssen Pharmaceuticals Ltd was run on a Hypersil Base-Deactivated Silica C18 column (100 × 4.6 mm, i.d., 3 µm) with a run time of 12.5 min. The developed UPLC method, with a run time of 7.5 min was determined to be accurate, precise, specific, robust and highly sensitive according to the International Conference on Harmonization guidelines. The method herein demonstrated a reduction in analysis time of 40%, allowing for a much higher sample throughput. A solvent consumption decrease of over 58% was also observed, which results in a dramatic reduction in running costs for Janssen Pharmaceuticals Ltd.