The present paper describes a simple, accurate and precise reversed phase HPLC method for rapid and simultaneous quantification of Ambroxol HCl, Guaifenesin and Levosalbutamol Sulphate in a cough syrup formulation. Separations were carried out on a phenomenex Luna C18 column (150 X 4.6 mm ID), 5 μm particle size. An isocratic elution system was developed using Methanol: Ammonium Acetate Buffer (50 mM) [45:55, v/v]. The elution of the analytes was achieved in less than 10 min with a flow rate of 1.0 ml/min. Detection was by UV absorbance at a wavelength of 236 nm. The detector response was linear in the concentration of 5-80 µg/ml for Ambroxol HCl, 10-120 µg/ml for Guaifenesin and 1-30 µg/ml for Levosalbutamol sulphate. The limit of detection (LOD) was found to be 0.019 µg/ml, 0.086 µg/ml and 0.0305 µg/ml, respectively and limit of quantitation (LOQ) values for AB, GF and LBS were found to be 0.057 µg/ml, 0.026 µg/ml and 0.092 µg/ml respectively. The intra and inter day variation was found to be less than 1%. The proposed method is simple, fast, accurate, precise and reproducible hence, it can be applied for routine quality control analysis of of Ambroxol Hcl, Guaifenesin and Levosalbutamol Sulphate in bulk and pharmaceutical formulations. All the parameters of validation were found in the acceptance range of ICH guideline.
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