Abstract

A VALIDATED REVERSE PHASE HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF GUAIFENESIN,AMBROXOL AND LEVOCETIRIZINE IN PHARMACEUTICAL DOSAGE FORMS

A.Srinivasa Rao*, K.L.N.N.S.V.K.Pavankumar, P.Satyanarayana, G. Subrahmanya Sastry

ABSTRACT

A simple, rapid, precise and accurate reverse-phase HPLC method was developed and validated for the simultaneous determination of Guaifenesin,Ambroxol and Levocetirizine in commercial tablets. The method has shown adequate separation for Guaifenesin,Ambroxol and Levocetirizine. Separation was achieved on PhenomenaxC18 (250 mm × 4.6mm; 5 µm) column using isocratic method with 0.1%OPA:Acetonitrile(60:40) system at room temperature and the detection was carried out at 290nm using photodiode array (PDA) detector. The linearity of the proposed method was investigated in the range of 50-150μg/ml (r2=0.999), 15-45μg/ml (r2=0.999), 2.5-7.5μg/ml (r2=0.999) for Guaifenesin,Ambroxol and Levocetirizine Respectively. The limit of detection (LOD) was 0.090,0.0234 and 0.012 for Guaifenesin,Ambroxol and Levocetirizine respectively. The limit of quantification (LOQ) was 0.290,0.0773 and 0.042 for Guaifenesin,Ambroxol and Levocetirizine respectively. The relative standard deviation (RSD) of six replicates is less than 2%. This HPLC method is applied successfully to the simultaneous quantitative analysis of Guaifenesin,Ambroxol and Levocetirizine in commercial tablets.

Keywords: RP-HPLC, Guaifenesine., Ambroxol, Levocetirizine.