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 HiQ Sil C18 column (250 mm×4.6 mm, 5 μm), with a mobile
phase comprising of a mixture of 0.01 mol/L potassium dihydrogen orthophosphate buffer and acetonitrile (70∶30,
v/v), and pH adjusted to 3 with orthophosphoric acid, at a flow rate of 1 mL/min, with detection at 247 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 10-60 μg/mL and that for AM was found to be 5-30
μg/mL. The correlation coefficients were 0.9996 and 0.9993 for GA and AM respectively. The results of the tablet
analysis (n=5) were found to be 99.94% with ±0.25% standard deviation (SD) and 99.98% with±0.36% SD for GA and AM
respectively. Percent recovery of GA was found to be 99.92%-100.02% and that of AM was 99.86%-100.16%. 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.
