Der Pharmacia Lettre
Abstract
Author(s): B.Prathap, G.Nagarajan, C.Roosewelt, V.Gopal
A simple, specific, accurate and precise high performance thin layer chromatographic method for
the analysis of gatifloxacin and ambroxol Hcl in combined tablet dosage forms is reported in this
paper. The method uses aluminium plates coated with silica gel 60 F254 as stationary phase and
n-butanol-water-methanol-ammonia 4:0.5:0.5:1(v/v) as mobile phase. Densitometric evaluation
of the separated bands was performed at 310 nm. The two drugs were satisfactorily resolved with
RF values 0.33 and 0.89 for gatifloxacin and ambroxol Hcl respectively. The respective
calibration plots were linear over the ranges 20-60 �Ž�¼g/ml and 2.5-12.5�Ž�¼g/ml per band. Intra-day
variation as RSD (%) was 0.21 for gatifloxacin and 0.24 for ambroxol Hcl. Interday variation, as
RSD (%) 0.04 for gatifloxacin and 0.4 for ambroxol Hcl. The method, which was validated in
accordance with ICH guidelines, can be used for analysis and is a rapid and cost-effective
quality-control tool for routine simultaneous analysis of gatifloxacin and ambroxol Hcl in
combined dosage forms.
