Development and Validation of RP-HPLC Method for Simultaneous Estimation of Levocloperastine Fendizoate and Chlorpheniramine Maleate in their Combined Dosage Form

A simple and rapid RP-HPLC method has been developed and validated for the simultaneous determination of Levocloperastine fendizoate and Chlorpheniramine maleate syrup formulation. Resolution of the analytes was achieved within 10min, employing a mixture of 10mM mobile phase Buffer (pH 6.5): Acetonitrile (50:50, % v/v) as isocratic mobile phase, pumped at 1.0mL/ min through a C18 column (5μm particle size). The detection wavelength for the analytes was 227nm. The system suitability parameters were found to be acceptable. The linearity of response (r2>0.999) in the appropriate ranges (from 50% up to 150% of the expected concentrations of the analytes in the formulations), method accuracy (RSD<2.0%), repeatability and intermediate precision (RSD<2.0%), were confirmed. Robustness result indicates that the methods performance can withstand small variations in method parameters. Satisfactory results obtained in terms of analyte recovery and RSD, while analyzing marketed pharmaceutical preparations. Hence the method can be useful for regular analysis of this combination in marketed syrup formulation.