Simultaneous Estimation of Gatifloxacin and Ambroxol HCl in tablet formulation by HPTLC Method

By B. Prathap, G.Nagarajan, C.Roosewelt, V.Gopal



Abstract

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 µg/ml and 2.5-12.5µg/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.

 

Key Words : Gatifloxacin, Ambroxol HCl, HPTLC, densitometry.

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