Application of TLC- Densitometry Method for Simultaneous Estimation of Tramadol Hcl and Paracetamol in Pharmaceutical Dosage Forms

A rapid, selective and precise high performance thin layer chromatographic method was developed and validated for simultaneous estimation of Tramadol Hcl and Paracetamol in pharmaceutical dosage forms. The method employed TLC aluminium plates precoated with silica gel 60F254 as the stationary phase. The solvent system consisted of Chloroform: Ethanol (7:3 v/v). This system was found to give compact spots for both Tramadol Hcl (Rf value of 0.48 ± 0.02) and Paracetamol (Rf value of 0.85 ± 0.02). Spectrodensitometric scanning-integration was performed at a wavelength of 254 nm. The polynomial regression data for the calibration plots showed good linear relationship with r2 = 0.9994 in the concentration range of 2.5 – 32.5mg for tramadol Hcl and 10 – 50mg for Paracetamol with r2 = 0.9991. The method was validated for precision, accuracy and recovery. The minimum detectable amounts were found to be 150 ng and 300 ng for tramadol Hcl and paracetamol respectively. The limits of quantification were found to be 450 ng for tramadol Hcl and 900 ng for paracetamol. Statistical analysis proves that the method is reproducible and selective for the simultaneous estimation of tramadol Hcl and paracetamol.