Untitled

Abstract

A simple, rapid, precise, accurate, reproducible and stability indicating RP-HPLC method was developed and validated for the simultaneous estimation of Desloratadine (DES), Ambroxol (AMB) and Pseudoephedrine (PSE) in bulk drug and pharmaceutical formulations. The chromatographic separation was achieved using C 18 reverse phase column (Kromasil 250mm x 4.6mm,5μm) , Buffer and Acetonitrile at the ratio 55:45 v/v as mobile phase, flow rate of 1ml/min, Column temperature maintained at 25˚C, detector wavelength 220nm and runtime 8min. Retention time was found 2.78min 3.34min and 4.75mins for Desloratadine, Ambroxol and Pseudoephedrine respectively. The developed new method was validated as per ICH guideline taking the parameters like accuracy, precision, linearity, limit of detection, limit of quantification, intermediate precision and robustness. In the linearity test correlation coefficient was found to be 0.999 for all the molecules, percentage relative standard deviation results from precision studies were 1.41, 0.53 and 1.12; mean percentage recoveries in accuracy studies were found to be 100.78%, 99.97% and 99.38% for desloratadine, ambroxol and pseudoephedrine respectively. Very low concentrations of LOD and LOQ indicate the method was highly sensitive enough. The designed validated method can be used effectively in the laboratory for regular determination of desloratadine, ambroxol and pseudoephedrine in formulation and bulk form.