Simultaneous Estimation of Gatifloxacin and Ambroxol HCl intablet formulation by HPTLC Method

[摘要] A simple, specific, accurate and precise high performance thin layer chromatographic method forthe analysis of gatifloxacin and ambroxol Hcl in combined tablet dosage forms is reported in thispaper. The method uses aluminium plates coated with silica gel 60 F254 as stationary phase andn-butanol-water-methanol-ammonia 4:0.5:0.5:1(v/v) as mobile phase. Densitometric evaluationof the separated bands was performed at 310 nm. The two drugs were satisfactorily resolved withRF values 0.33 and 0.89 for gatifloxacin and ambroxol Hcl respectively. The respectivecalibration plots were linear over the ranges 20-60 μg/ml and 2.5-12.5μg/ml per band. Intra-dayvariation as RSD (%) was 0.21 for gatifloxacin and 0.24 for ambroxol Hcl. Interday variation, asRSD (%) 0.04 for gatifloxacin and 0.4 for ambroxol Hcl. The method, which was validated inaccordance with ICH guidelines, can be used for analysis and is a rapid and cost-effectivequality-control tool for routine simultaneous analysis of gatifloxacin and ambroxol Hcl incombined dosage forms.

[学科分类] 药理学