Development and Validation of RP-HPLC Method for Simultaneous Estimation of Levocetirizine Dihydrochloride and Phenylephrine in Bulk and In Tablet Dosage Form

  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.