European Journal of Biomedical and Pharmaceutical Sciences

RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF AMBROXOL MONTELUKAST AND LEVOCETRIZINE BY USING SOLID DOSAGE FORM

Md. Ameena Khanam*

ABSTRACT

A simple and selective LC method is described for the determination of Ambroxol, Montelukast and Levocetirizine dosage forms. Chromatographic separation was achieved on a c18 column using mobile phase consisting of a mixture of Phosphate buffer pH: 4 Acetonitrile (55:45v/v/v), with detection of 275nm. Linearity was observed in the range 40-120 µg /ml for Ambroxol(r2 =0.999) 20-60µg/ml for Montelukast (r2 =0.999) & 5-15µg /ml for Levocetirizine (r2 =0.999) 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.

Keywords: Ambroxol, Montelukast, levocetrizine, RP-HPLC, validation.