Journal des techniques de chromatographie et de séparation
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Development and Validation of HPLC Method for the Determination of Alcaftadine in Bulk Drug and its Ophthalmic Solution

Mishra PR, Satone D and Meshram DB

A simple, precise and accurate stability indicating RP-HPLC method was developed for the estimation of Alcaftadine in bulk drug and its ophthalmic dosage form. Chromatographic separation of target analyte and degradation products was achieved using Enable HPLC ODS C18 G (250 × 4.6 mm, 5 μm) column and mobile phase comprising of methanol: water, 50:50% v/v at a flow rate of 1.2 ml/min with UV detection at 282 nm. The correlation coefficient (r2) was found to be 0.999 in the concentration range of 1-16 μg/ml. The retention time was found to be 3.15 min. The limit of detection and limit of quantitation was found to be 0.25 μg/ml and 0.75 μg/ml respectively. Stress degradation of Alcaftadine was carried out under stress conditions like acid and base hydrolysis, oxidation, thermal and photolytic stress. The degradation products generated as a result of stress did not show any interference to the detection of Alcaftadine. The developed method was validated, and selectivity of the method was demonstrated by its ability to quantify the target analyte in presence of its degradation products.