Abstract

VALIDATED RP-HPLC METHODFOR SIMULTANEOUS ESTIMATION OF PHENYLEPHRINE AND LEVOCETIRIZINE IN PHARMACEUTICAL DOSAGE FORM

Sunitha.P.G, Ilango. K

ABSTRACT

The present work reports a reversed phase high performance liquid chromatography (RP-HPLC) methodfor the simultaneous determination of phenylephrine and levocetirizine in pharmaceutical dosage form. HPLC was performed on a Thermo Hypersil C18 column (250×4.6 mm i.d., 5 μm particle size) using a mixture of Methanol: 0.05M Dibasic phosphate in the ratio of 70:30v/v as mobile phase. Ultraviolet detection was carried out at 230nm. The retention time of phenylephrine and levocetirizine were found to be 3.915 min and 7.292 min respectively. The linear regression analysis data for the calibration plots showed good linear relationship with r2 = 0.9986 and 0.9988 for
PHE and LEV, respectively, in the concentration range of 4-14 μg mL-1 for PHE and 2-12 μg mL-1 for LEV. The method was validated for precision, robustness, specificity and accuracy. The limits of detection and quantitation were 0.34 and 0.98 μg mL-1, respectively, for PHE and 0.23 and 0.70μg mL-1, respectively, for LEV. The method was validated as per ICH guidelines. The proposed method can be applied for identification and quantitative determination of PHE and LEV in bulk drug and drug formulation.

Keywords: RP-HPLC, Phenylephrine, Levocetirizine, Formulation, Validation.