Simultaneous estimation of levofloxacin and ambroxol hydrochloride from tablet dosage form using RP-HPLC

Abstract

A reversed phase high performance liquid chromatography (RP-HPLC) method was developed, validated and used for the quantitative determination of levofloxacin (LE) and ambroxol hrdrochloride (AM) from its tablet dosage form. Chromatographic separation was performed on a Intersil ODS-3u C18 column (250mmx4.6mm, 5µm) with a mobile phase comprising of a mixture of buffer: acetonitrile: methanol (75:10:15v/v/v) and pH adjusted to 3 with ortho phosphoric acid, at flow rate of 1ml/min, with detection at 215nm. As per International Conference on Harmonisation (ICH) guidelines the method was validated for linearity, accuracy, precision, limit of detection, limit of quatification and robustness. Linearity of LE was found to be in the range of 19.5-45.5µg/ml and that for AM was found to be 3-7µg/ml. the correlation coefficient were 0.9972 and 0.9999 for LE and AM respectively. The results of tablet analysis were found to be 101.1 and 102.6 for LE and AM respectively. Percentage recovery of LE was found to be 97.20% - 99.98% and that of AM was 98.05% - 99.9%. The assay experiment shows that the method is free from interference of excipients. This demonstrates that the developed HPLC method is simple, linear, precise and accurate and can be conveniently adopted for the routine quality control analysis of the tablet.