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1 Acta Chromatographica

1 2008

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

Gandhi S. V., Barhate N. S., Patel B. R., Panchal D. D., Bothara K. G.

Acta Chromatographica

2008

Vol. 20, no. 2

175-182

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 F254 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 RF values 0.29 š 0.019 and 0.74 š 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 š 0.282 for aceclofenac and 0.354 š 0.212 for paracetamol. Interday variation, as RSD (%) š SE, was 0.57 š 0.41 for aceclofenac and 0.90 š 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 costeffective quality-control tool for routine simultaneous analysis of aceclofenac and paracetamol in combined dosage forms.