Development and Validation of a New Stability Indicating Reversed Phase Ultra-Performance Liquid Chromatography Method for the Determination of Cinnarizine and Domperidone Fixed-Dose Combination

Abstract

Aim: Vertigo, nausea, motion sickness and vomiting due to gastrointestinal and vestibular diseases are controlled by the Combination of Cinnarizine (CIN) and Domperidone (DOM). A rapid, stable and accurate RP-UPLC method was developed and validated for both medicines in the medicinal formulations.Materials and Methods: An ACQUITY UPLC HSS C18 column (100×2.1 mm, 1.8 μm) with eluate of 0.1% formic acid buffer and acetonitrile in 35:65 ratio, at injected flow of 0.3 mL/min for separation. The column was heated to 30ºC and the detection was made at 226 nm.Results: The two have been proven to retain for 1.170 and 1.574 min, respectively. The approach proved to have good accuracy, as %RSD of 0.8 for both medications. The recovery percentages of 99.82% and 99.50% for cinnarizine and domperidone, respectively, showed excellent accuracy. Limit of detection and Limit of quantification values for cinnarizine of 0.07 and 0.22, and domperidone of 0.02 and 0.05, respectively. The run time and retention time reductions indicated that the devised approach was easy to use, quick and cost-effective.Conclusion: For this reason, periodic quality control testing of these two medications in drug products can be readily accomplished with the adopted approach.

Keywords: Cinnarizine; Domperidone; Method validation; Pharmaceutical analysis; RP-UPLC