Optimization and Validation of RP-HPLC Method for Quantification of Timolol Maleate in Bulk Drug and Ophthalmic Formulation

This research presents a comprehensive evaluation of a Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method developed and validated for the quantification of Timolol Maleate in bulk and ophthalmic formulations. The method optimization was conducted using a C18 column with a mobile phase consisting of methanol and 0.05% formic acid in a 75:25 v/v ratio, a flow rate of 0.7 mL/min, and detection at 294 nm. Validation studies were performed as per ICH guidelines, assessing linearity, accuracy, precision, specificity, robustness, LOD, and LOQ.