RP-HPLC Method for Simultaneous Estimation of Domperidone in Combination with Esomeprazole Magnesium in Solid Dosage Form

Abstract

The present work describes a reverse phase high performance liquid chromatographic method for simultaneous estimation of domperidone in combination with esomeprazole magnesium in capsule formulation. Chromatography was performed on a Inertsil C₁₈ (250 mm × 4.6 mm i.d. particle size 5 μm) column in isocratic mode with mobile phase containing 0.05 M potassium dihydrogen phosphate:acetonitrile:methanol in the ratio 40:30:30 % (v/v/v) and pH of the final mobile phase was adjusted to 7.44 ± 0.03 with 5 M KOH. The flow rate was 1.0 mL/min and the eluent was monitored at 284 nm. The selected chromatographic conditions were found to effectively separate domperidone (run time 9.74 ± 0.33 min) and esomeprazole magnesium (run time 7.16 ± 0.44 min). Linearity for domperidone and esomeprazole magnesium found in the range of 3-300 and 4-400 μg/mL, respectively. The proposed method was validated by different parameters and was found to be accurate, precise, reproducible and specific and can be used for simultaneous analysis of these drugs in capsule formulation.