Reverse phase-UPLC method of analysis for simultaneous estimation of Levosalbutamol sulphate, Guaiphenesin and Ambroxol hydrochloride in pharmaceutical cough, cold liquid dosage forms

Abstract

The three most drug combinations for cough, cold are widely used worldwide now a day. The purpose of the study was to build up an innovative RP-UPLC technique for simultaneous estimation of Levosalbutamol Sulphate (LEV), Guaiphenesin (GUA) and Ambroxol Hydrochloride (AMB) in liquid dosage forms. Chromatography was carried out on UHPLC (WATERS)_SYMMETRY® C18 4.6mm x 1000mm, 3.5µm, (Agilent - Zorbax Eclipse Plus C18 – Rapid Res- olution) with an isocratic mobile phase with pH 3.0 composed of buffer, methanol and Acetonitrile (60:20:20) with a flow rate of 0.8mL/min. The detection was carried out with column temperature at 25°C using a UV detector at 276nm. Validation parameters like linearity, specificity, precision, accuracy, limit of detection (LOD), limit of quantification (LOQ), system suitability, Solutions stability and robustness were considered as affirmed in the ICH guidelines. Retention times for LEV, GUA & AMB were 1.07 min, 1.99 min & 3.55 min respectively. The assay of syrups with the relative standard deviation found to be less than 2%. The parameters values were found, and the method was found to be satisfactory. This validated UHPLC method is cost- effective, receptive and precise than other chromatographic methods.