A New analytical method development and validation of Ambroxol, Montelukast and Levocetirizine in Tablet dosage form by RP-HPLC method

Abstract

A simple and selective LC method is described for the determination of Ambroxol, Montelukast and Levocetirizine in tablet dosage forms. Chromatographic separation was achieved on a c18 column using mobile phase consisting of a mixture of Triethylamine Buffer:ACN:Methanol (20:30:50) with detection of 280 nm. Linearity was observed in the range 7.7-22.5 µg/ml for Ambroxol (r 2=0.999) and 1.25-3.75 µg/ml for Montelukast (r2=0.998) and 5-15 µg/ml for Levocetirizine (r2=0.997) for the amount of drugs estimated by the proposed methods was in good agreement with the label claim. The proposed methods were validated. The accuracy of the methods was assessed by recovery studies at three different levels. Recovery experiments indicated the absence of interference from commonly encountered pharmaceutical additives. The method was found to be precise as indicated by the repeatability analysis, showing %RSD less than 2. All statistical data proves validity of the methods and can be used for routine analysis of pharmaceutical dosage form.