RP- HPLC Method Development and Validation for the Estimation of Moxifloxacin Hydrochloride in Ophthalmic Dosage Form

A simple, precise, fast, sensitive and accurate RP-HPLC method has been established for estimation of Moxifloxacin Hydrochloride using Paracetamol as an Internal Standard. The separation was accomplished within 10 minutes by using reverse phase Qualisil BDS C18 column (250mm x 4.6mm, 5μm), using mobile phase consisting Methanol:0.5% OPA (46:54 v/v), pH maintained with TEA to 3 and flow rate 1ml/min. The wavelength was detected by UV detector at 288nm. Developed method underwent validation in compliance with ICH guidelines, assessing critical parameters such as specificity, linearity, accuracy, precision, stability, as well as the limits of detection (LOD) and quantification (LOQ), and can be applied for the determination of this drug in commercial ophthalmic preparations. MOX was satisfactorily eluted with retention time 5.85min. Linearity range was 5-30μg/ml for MOX and correlation coefficient was 0.9992 for MOX. The analytical methods and solvents were designed to provide good results in a short analytical time with economic benefits. The established analytical method is simple, fast, precise and reproducible and does not require expensive and intricate equipments.