Ebastine

A simple, sensitive and reproducible stability indicating RP-HPLC method for the simultaneous determination of Phenylephrine and Ebastinein bulk and Pharmaceutical dosage formhas been developed and validated. Chromatographic separation was carried out on kromasil C18 (250×4.6mm, 5mparticle size) column using a mobile phase composed of Phosphate buffer (adjusted to pH 5.0 with dilute OPA): acetonitrile: methanol in the ratio of 30:45:25 %v/v/vat a flow rate of 0.8 ml/min. The analyte was monitored using PDA detector wavelength at 211 nm. The retention time was found to be 2.295 min and 4.225 min for Phenylephrine and Ebastine respectively. The proposed method was found to be having linearity in the concentration range of 25-150µg/ml for both Phenylephrine(r20.99996)and Ebastine(r20.99987)respectively. The developed method has been statistically validated according to ICH guidelines. Stress testing which covered acid, alkali, peroxide, photolytic and thermal degradation was performed on under test to prove the specificity of the method and the degradation was achieved. The proposed method can be successfully applied for the stability indicating RP-HPLC simultaneous determination of Phenylephrine and Ebastine in bulk and combined tablet dosage form and in routine quality control analysis.

A specific and accurate reverse phase high performance liquid chromatographic method was developed for the simultaneous determination Ebastine (EBA) and Montelukast Sodium (MONTE) in Combined dosage forms. The analysis was carried out using Phenomenex  C18, column (250 mm × 4.6 mm id, 5 µm particle size) with Mobile phase consisting of  Methanol : Phosphate buffer (65:35 v/v) pH 5.0+0.05 was  pumped at a flow rate was 1.0 ml/ min and  Quantification was achieved with photodiode array (PDA) detection at 261 nm over the concentration range of 10 - 50 µg/mL for ebastine & Montelukast Sodium  with mean recovery of 100.32 ± 0.85 % and 100.15 ± 0.94 % for Ebastine and Montelukast Sodium, respectively. These methods were found to be simple, sensitive, accurate, precise and economical and applicable for the simultaneous determination of Ebastine & Montelukast Sodium in combined dosage form.