Mohammad Yunoos

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 simple and precise stability indicating RP-HPLC method was developed and validated for the simultaneous determination of Hydrochlorothiazide (HCTZ) and Nebivolol Hydrochloride (NBV) inbulk and Pharmaceutical dosage forms. Chromatography was carried out on Thermo Hypersil BDS C 18 (150 x 4.6 mm, 5mparticle size) column using a mobile phase of phosphate buffer (adjusted to pH 6.5 with dilute orthophosphoric acid): acetonitrile (40:60% v/v) at a flow rate of 0.8 ml/min. The analyte was monitored using PDA detector at 282 nm. The retention time was found to be2.4 min and 4.0min for Hydrochlorothiazide and Nebivolol Hydrochloride respectively. The proposed method was found to be having linearity in the concentration range of 6.25-37.5 µg/ml for Hydrochlorothiazide (r2 0.9999) and 2.5-15 µg/ml for Nebivolol Hydrochloride (r2 0.9999) respectively. The mean % recoveries obtained were found to be 99.93 % for Hydrochlorothiazide and 100.03% for Nebivolol Hydrochloride respectively. 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 developed method has been statistically validated according to ICH guide lines and found to be simple, precise and accurate with the prescribed values. Thus the proposed method was successfully applied for the stability indicating simultaneous determination of Hydrochlorothiazide and Nebivolol Hydrochloridein bulk and Pharmaceutical formulations and in routine quality control analysis.