Phenylephrine

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.

  The present work deals with development and validation for simultaneous determination of antihistaminic drugs in pharmaceutical formulations. A rapid, precise and specific high performance liquid chromatography (RP-HPLC) method was developed for Levocetirizine dihydrochloride and Phenylephrine. Chromatographic separations was achieved on Waters Younglin system C-18 (5μm, 250×4.6 mm) HPLC column within a short runtime of 10 min. HPLC system having isocratic mode, with mobile phase containing methanol : water (pH 3) (70:30% v/v) and flow rate maintained at 1.0 mL/min was used. Effluents were monitored at 230 nm. Retention time of Levocetirizine dihydrochloride and Phenylephrine were found to be 2.6 and 4.6 min respectively. Linearity was studied in the concentration range of 2 to 12 μg/mL and 12 to 72 μg/ mL for Levocetirizine dihydrochloride and Phenylephrine respectively, with a correlation coefficient of 0.998 and 0.999 respectively. The proposed method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness.