Method Development and Validation of Alcaftadine by UHPLC in Bulk and Dosage Form

This research developed and validated a new, simple sensitive, suitable, economical, accurate, and robust ultra-high performance liquid chromatography (UHPLC) method for determining Alcaftadine in bulk drug and ophthalmic dosage formulation. The separation was performed using an HPLC method with a UV detector and Open lab EZchrome workstation program, Kromasil C18, 250mm X 4.6mm ID, 2.7μm Acetonitrile: 0.05% OPA (60:40%V/V) with a flow rate of 1.0mL/min and detected at 282nm. The developed UHPLC method yielded a suitable retention time for Alcaftadine of 2.20min, which was optimised using a trial-and-error basis. The linearity of the determined method was found a correlation coefficient (r2) of 0.9998 over the concentration range of 2.0-30.0μg/mL. The percentage RSD for the method's precision was found to be less than 2.0percent. The percentage recovery was discovered within the limit 0.259ug/mL and 0.784ug/mL were found to be the LOD and LOQ, respectively. The developed and validated UHPLC system takes less time and cheaply can be used in the industry for routine quality control/analysis of bulk drugs and marketed Alcaftadine products. In present studies, the retention time was less than previously reported. The developed method was validated in terms of specificity, linearity, accuracy, precision and robustness according to the ICH guidelines.