A Rapid and Simultaneous Determination of Ambroxol Hydrochloride, Methyl Parabene and Propyl Paraben in Mucol Ambroxol Syrup Dosage Form.
Ambroxol HCl is an active compound that improve the exploration and a mucolytic activity for the treatment of bronchial asthma and chronic bronchitis.A method is delineate ambroxol, trans-4-(2-amino-3,5-dibromobenzylamino) cyclohexanol, hydrochloride, methyl and propyl parabeneseparation by HPLC, with UV detection at 247 nm in a syrup as pharmaceutical presentation. The optimal conditions maintained were column symmetry shield RPC8, 5 microm 250 x 4.6 mm, and methanol/H3PO4 8.5 mM/triethylamine pH=2.8) 40:60 v/v. The validation was carried out using ICH guildlines. HPLC assay method was validated for linearity, precision, accuracy, specificity and robustness. The developed and validated method can be used extensively for quality control and assurance purposes of Ambroxol hydrochloride and Parabenes.