A New RP-HPLC Method Development and Validation of Simultaneous Estimation of Levosalbutamol, Ambroxol and Guaiphenesin by Syrup Formulation

Author(s): Arkoti Chaitanya*, R. V. Valli Kumari, S. Marakatham and Meruva Sathish Kumar**

Abstract: A procedure using RP-HPLC is developed, validated and employed for concurrent estimation of ambroxol, guaiphenesin and levosalbutamolin syrup formulation. The procedure involves separation and analysis of ambroxol, guaiphenesin and levosalbutamolin Waters C18 column (stationary phase) and 60% 0.1M sodium dihydrogen phosphate (pH 5.0) and 40% acetonitrile mixture (mobile phase). The levosalbutamol, guaiphenesin and ambroxol were eluted at 4.767 min, 6.409 min and 9.850 min, respectively. Linear ranges are 0.5-1.5 μg/ml, 50-150 μg/ml and 15-45 μg/ml with regression coefficient values of 0.9999, 0.9994 and 0.9991 for levosalbutamol, guaiphenesin and ambroxol, respectively. The determined LOD values are: levosalbutamol – 0.022 μg/ml, guaiphenesin – 0.1115 μg/ml and ambroxol – 0.072 μg/ml, and determined LOQ values are: levosalbutamol – 0.072 μg/ml, guaiphenesin – 0.3716 μg/ml and ambroxol – 0.239 μg/ml. Validation parameters tested following guidelines of ICH are good enough for the intended assay. The method demonstrated as appropriate procedure for assay of ambroxol, guaiphenesin and levosalbutamolin syrup formulation with excellent assay percentage values.

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