A validated densitometric method for analysis of aceclofenac and paracetamol as the bulk drugs and in combined tablet dosage forms

A simple, specific, accurate, and precise high-performance thin-layer chromatographic method for analysis of aceclofenac and paracetamol in combined tablet dosage forms is reported in this paper. The method uses aluminium plates coated with silica gel 60 F 254 as stationary phase and ethyl acetate-n-butanol-glacial acetic acid 7.5:2.5:0.005 (v/v) as mobile phase. Densitometric evaluation of the separated bands was performed at 270 nm. The two drugs were satisfactorily resolved with R F values 0.29 plus or minus 0.019 and 0.74 plus or minus 0.025 for aceclofenac and paracetamol, respectively. The respective calibration plots were linear over the ranges 50-1000 and 200-1500 ng per band. Intra-day variation, as RSD (%), was 0.420 plus or minus 0.282 for aceclofenac and 0.354 plus or minus 0.212 for paracetamol. Interday variation, as RSD (%) plus or minus SE, was 0.57 plus or minus 0.41 for aceclofenac and 0.90 plus or minus 1.09 for paracetamol. The method, which was validated in accordance with ICH guidelines, can be used for analysis of ten or more formulations on a single plate and is a rapid and cost-effective quality-control tool for routine simultaneous analysis of aceclofenac and paracetamol in combined dosage forms.