Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF AMBROXOL AND DESLORATADINE IN ITS PHARMACEUTICAL DOSAGE FORM BY RP-HPLC

*Prince Francis Moses, Prathap Singh, Alagar Raja, David Banji

ABSTRACT

The present manuscript describes a new simple, specific and accurate reverse phase high performance liquid chromatographic method for the simultaneous determination of ambroxol and desloratadine in its tablet dosage forms. The estimation was carried out by using Inertsil C18(4.6 × 250 mm, 5 um) column with mobile phase containing Acetonitrile: Ammonium acetate buffer in the ratio of 40: 60 (v/v, 0.2ml of Triethylamine) and the buffer pH was maintained at 3.5 and adjusted with 0.01M glacial acetic acid, which is pumped at a flow rate of 1.0 ml/min.The Injection volume is 20μl and detection was monitored at 252 nm. The peaks obtained were sharp with retention times of ambroxol and desloratadine were 4.35 min and 6.132 min, respectively. The linearity for ambroxol was in the range of 18.75- 112.5μg/ml, and desloratadine shows linearity in the range of 1.25- 7.5μg/ml respectively. The % recoveries of ambroxol and desloratadine were found to be in the range of 99.57% and 99.7% respectively. The proposed method was validated and successfully applied to the estimation of ambroxol and desloratadine in combined tablet dosage forms

Keywords: Ambroxol, desloratadine, simultaneous estimation, RP-HPLC.