Development and Optimization of a Stability-Indicating RP-HPLC Method for the Determination of Travoprost in Bulk and Dosage Forms

Abstract

Travoprost is commonly employed in the management of glaucoma due to its efficacy in reducing intraocular pressure. This study aimed to develop and validate a straightforward, sensitive, precise, and specific reverse-phase high-performance liquid chromatography (RP-HPLC) method for the quantification of Travoprost in both raw materials and ophthalmic dosage forms. Chromatographic separation was performed using a Hypersil BDS C18 column (250 × 4.6 mm, 5 μm) with a mobile phase consisting of water (pH=2 adjusted using OPA), methanol and acetonitril in a ratio of 80:10:10 (v/v/v), at a flow rate of 1 mL/min. Detection was carried out using a photodiode array (PDA) detector at 233 nm, and the column temperature was maintained at 40°C. Travoprost exhibited a retention time of 6.30 ± 0.1 minutes. Method validation was conducted in accordance with ICH guidelines. The calibration curve demonstrated linearity across a concentration range of 25% to 150% of the working concentration, with a correlation coefficient (r²) of 0.9993. The limit of detection (LOD) and limit of quantification (LOQ) were determined to be 0.002 μg/mL and 0.007 μg/mL, respectively. Therefore, the validated RP-HPLC method is suitable for routine quality control analysis of Travoprost in ophthalmic formulations.