Simultaneous determination of gatifloxacin and ambroxol hydrochloride from tablet dosage form using RP-HPLC

Abstract

A reversed-phase high performance liquid chromatography (HPLC) method was developed, validated, and used for the quantitative determination of gatifloxacin (GA) and ambroxol hydrochloride (AM), from its tablet dosage form. Chromatographic separation was performed on a Thermo Hypersil Keystone ODS C₁₈ column (250 mm × 4.6 mm, 5 μm), with a mobile phase comprising of a mixture of phosphate buffer and acetonitrile (60:40, v/v), and pH adjusted to 3 with ortho phosphoric acid, at a flow rate of 1 mL/min, with detection at 250 nm. Separation was completed in less than 10 min. As per International Conference on Harmonisation (ICH) guidelines the method was validated for linearity, accuracy, precision, limit of quantitation,limit of detection, and robustness. Linearity of GA was found to be in the range of 20–100 μg/mL and that for AM was found to be 5–15 μg/mL. The correlation coefficients were 0.9989 and 0.9966 for GA and AM respectively. The results of the tablet analysis (n= 5) were found to be 99.86% and 100.09% for GA and AM respectively. Percent recovery of GA was found to be 98.2%–101.02% and that of AM was 98.86%–102.05%. 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.