Development and validation of HPTLC method for simultaneous analysis of Tramadol HCl and paracetamol in fixed-dose combination tablets

This paper presents the development and validation of an improved method for the simultaneous analysis of Tramadol HCl (TMD) and paracetamol (PAR) using high-performance thin-layer chromatography (HPTLC) with densitometric detection. Separation was performed on silica gel 60F(254) plates. The mobile phase is comprised of chloroform, methanol and ethyl acetate (7.5 : 1.5 : 0.5, v : v : v). The detection wavelength was 254 nm. The R-f values of TMD and PAR were found to be 0.2 +/- 0.03 and 0.4 +/- 0.04, respectively. An F-test indicated that calibration graphs were adequately linear at the evaluated concentration ranges. The pooled %RSD for repeatability of the percentage amount recovered for TMD and PAR were found to be 0.73 and 0.49, and the pooled %RSD for time-different intermediate precision were 1.72 and 1.21 respectively. The percentage recoveries for the trueness were 98.6% +/- 1.5 for TMD and 99.3% +/- 1.7 for PAR (n = 3). The developed HPTLC method was found to be new, accurate, sensitive, precise and Was successfully used to analyze fixed-dose tablets samples of TMD and PAR.