A Novel RP-UPLC Method for Elution and Quantification of Domperidone and Lansoprazole in Capsules: a Chemometric Optimization Approach

The increasing prevalence of multi-component pharmaceutical formulations to enhance therapeutic effectiveness creates challenges in analysis procedures. These challenges require developing new, fast, reliable, and cost-effective methods for simultaneous drug quantification. In this study, a new reversed-phase ultra-performance liquid chromatography (RP-UPLC) method was developed for the simultaneous elution and quantification of domperidone (DMP) and lansoprazole (LSP) in a binary solid dosage form. To improve the efficiency and selectivity of the method, a chemometric optimization strategy based on a full factorial design (3³) was applied during the method development stage. This approach allowed accurate adjustment of key chromatographic variables, resulting in high resolution and significantly reduced analysis time. The optimized method achieved complete separation of LSP and DMP with retention times of 0.61 and 1.01 min, respectively, within a total runtime of just 2.0 min. Quantification was carried out at 283.0 nm using linear regression models based on the relationship between peak area and concentration. The method was validated and successfully applied to commercial capsule samples, showing its suitability for routine quality control. Overall, integrating chemometric design into UPLC method development proved to be a faster and more economical alternative to traditional methods for multi-component pharmaceutical analysis.