Abstract

A RESEARCH ARTICLE ON ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF HYDROCODONE AND PSEUDOEPHEDRINE USING UPLC

Afsha Fatima* and Dr. S. H. Rizwan

Abstract

A simple and selective method is described for the determination of hydrocodone and pseudoephedrine in liquid dosage forms. Chromatographic separation was achieved on a Water using mobile phase consisting of a mixture of 60 volumes of Methanol, 40 volumes of water with detection of 243 nm. Linearity was observed in the range 20 - 100 μg/ml for hydrocodone (r2 =0.999) and 60-140 μg /ml for pseudoephedrine (r2 =0.999) for the amount of drugs estimated by the proposed methods was in good agreement with the label claim. The column used was waters acquity C18125A (100*2.2mm1D) 1.8um using mobile phase as phosphate buffer (PH=6.8) and acetonitrile (ratio=60:40) The proposed methods were validated. The accuracy of the methods was assessed by recovery studies at three different levels. The method was found to be precise as indicated by the repeatability analysis, showing %RSD less than 2. Lod was found to be 0.32133μg/ml (hydrocodone) and 0.82718μg/ml (pseudoephedrine) Loq was found to be 5.84μg/ml (hydrocodone) and 2.506μg/ml (pseudoephedrine). Assay limit range 99-100.06%. All statistical data proves validity of the methods and can be used for routine analysis of pharmaceutical dosage form.

Keywords: hydrocodone, pseudoephedrine, waters acquity, chromatography, assay.