Development and Validation of RP-HPLC Method for Estimation of Alcaftadine in Bulk Drug and Dosage Form

A new, sensitive, suitable, economic, accurate, and robust reversed-phase high-performance liquid chromatography (RP-HPLC) method for the determination of Alcaftadine in bulk drug and opthalamic formulation was developed and validated in this research. The separation was performed using a HPLC method with a UV detector and Openlab EZchrome workstation programme, Kromasil C18, 250 mm X 4.6mm ID, 5 μm Acetonitrile: 0.1 % OPA (90:10%V/V) with a flow rate of 1.0 mL/min and detected at 282 nm. The developed RP-HPLC method yielded a suitable retention time for Alcaftadine of 3.05 min, which was optimized using trial and error basis. The linearity of the determined method was found a correlation coefficient (r2 ) of 0.9999 over the concentration range of 0.5- 7.5µg/mL. The percentage RSD for the method's precision was found to be less than 2.0 percent. The percentage recovery was discovered within the limit 0.095 ug/mL and 0.288 ug/mL were found to be the LOD and LOQ, respectively. The developed and validated RP-HPLC system takes less time and can be used in the industry for routine quality control/analysis of bulk drug and marketed Alcaftadine products. In present studies, the retention time was less than previous reported.