RP-HPLC Method Development and Validation of Ebastine in Bulk and Injectable Dosage Form

Abstract

The current study presents the development and validation of a novel reverse-phase high-performance liquid chromatography (RP-HPLC) method for the quantification of Ebastine in injectable formulations. A comprehensive literature review revealed the absence of reported RP-HPLC methods for the determination of Ebastine in this dosage form. The method was developed using an InertSustain AQ-C18 column (150 × 4.6 mm, 5 µm) and a mobile phase comprising a pH 5.5 buffer and acetonitrile in a 30:70 (% v/v) ratio. The mobile phase was pumped at a flow rate of 2.0 mL/min, and detection was carried out at 255 nm using a PDA detector. Ebastine exhibited a distinct retention time at 4.072 minutes. The method was validated in accordance with ICH guidelines for parameters including system suitability, specificity, linearity, accuracy, precision, robustness, and filter validation. Results demonstrated excellent linearity (R² = 0.9998), high recovery (100.4%), and satisfactory system suitability with %RSD of 0.041, a symmetry factor of 0.94, and 6029 theoretical plates. Specificity studies confirmed no interference from diluent, placebo, or degradation products. The method was robust and filter validation indicated minimal assay variability among different filter types. The developed method is accurate, precise, rapid, and cost-effective, making it suitable for routine quality control analysis of Ebastine in injectable dosage forms.