Abstracta
A simple, economical, specific, accurate & precise validated Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method has been developed for simultaneous estimation of Cetirizine HCl and Phenylephrine HCl in combined dosage form. The RP-HPLC separation was achieved on Phenomenex Luna C18 column (250 mm x 4.6 mm i.d., 5 µm particle size) at ambient temperature using mobile phase Methanol : Water(pH 3.5 ± 0.02) (80 :20 v/v) at flow rate 1.0 mL/min. Quantification was achieved with photodiode array (PDA) detection at 225 nm. The retention time was found to be 4.92min and 2.24 min for cetirizine HCl & phenylephrine HCl respectively. The method was validated in terms of linearity, precision, accuracy, LOD, LOQ and ruggedness according to ICH guideline. The linearity was found to be 5-30 µg/ml with correlation coefficient 0.9999 and 0.995.The mean recovery was found to be 100.73 ± 0.69 % and 100.43 ± 0.503 % for Cetirizine HCl and Phenylephrine HCl, respectively. There was no chromatographic interference of any excipients of tablet dosage form. The developed method with good separation, successfully applied for determination of cetirizine HCl and Phenylephrine HCl in its pharmaceutical dosage form.
