ABSTRACT:
A simple, accurate, reproducible, rapid and precise high-performance thin-layer chromatographic method has been established and validated for simultaneous determination of Aceclofenac and Paracetamol in bulk and combined tablet dosage form and from biological fluids. Both the drugs were separated on aluminum plates precoated with silica gel 60 F254; Toluene: n- Butanol (7:3v/v) was used as mobile phase. Quantitative analysis was performed by densitometric scanning at 263 nm. The RF values of aceclofenac and paracetamol were 0.14 and 0.43, respectively. The calibration plot was linear over the range of 200–1200 ng/spot for aceclofenac and paracetamol, with correlation coefficients, r, 0.9979 and 0.9995, respectively. Recovery of aceclofenac and paracetamol was 100.14–101.80 and 100.04–100.32%, respectively. The suitability of densitometric TLC for quantitative analysis of these compounds was proved by validation in accordance with the requirements of ICH guidelines. The recovery of aceclofenac and paracetamol from biological fluids (albumin and plasma) by solvent - solvent extraction using ethyl acetate: acetonitrile (3:1v/v) was 89-90% and 90-98% respectively.