Development and Validation of Second Order Derivative Spectrophotometric Method for Simultaneous Estimation of Desloratidine and Pseudoephedrine HCl In Combined Dosage Form

A simple, rapid and specific Second order derivative spectroscopic method with good sensitivity was developed and validated for the simultaneous determination of Desloratidine and Pseudoephedrine HCl in pharmaceutical dosage form. In Ethanol, the quantitative determination of both drugs carried out using second derivatives values measured at 268 and 271 nm for Desloratidine and Pseudoephedrine HCl respectively using a Shimadzu UV-Visible spectrophotometer. In this proposed method both drugs obeyed linearity within the concentration range of 5-30 µg/ml and 80-800 µg/ml for Desloratidine and Pseudoephedrine HCl respectively. The low RSD values indicate good precision and high recovery values indicate accuracy of the proposed method. The proposed method has been applied to the determination of drugs in commercial formulations. Assay results were in good agreement with label claim. The method was validated as per ICH guidelines. The developed method was simple, accurate, precise, specific, sensitive and reproducible which can be efficiently and easily applied to pharmaceutical dosage forms.