Original Articles: 2013 Vol: 5 Issue: 11
Simultaneous estimation of tolperisone hydrochloride and paracetamol in combined tablet dosage form by validated normal phase HPTLC method
Abstract
A sensitive, simple, accurate, precise and selective validated HPTLC method for simultaneous determination of Tolperisone Hydrochloride and Paracetamol in tablet formulation with densitometric detection has been developed and validated. Chromatographic separation was achieved on Merck aluminum HPTLC plates precoated with silica gel 60 F254. The solvent system comprised of toluene: ethyl acetate: methanol (1: 7: 3, v/v/v) and detection wavelength was 256 nm in reflectance-absorbance mode. The retardation factor for Tolperisone Hydrochloride and Paracetamol were found to be 0.39 ±0.01 and 0.79 ± 0.02, respectively. Results were found to be linear over a range of 50-800 ng band-l and 100-800 ng band-l for Tolperisone Hydrochloride and Paracetamol, respectively. The proposed densitometric method was applied for the analysis of tablet formulation. Percentage assay for Tolperisone Hydrochloride and Paracetamol were found to be 98.47 and 99.23 %, respectively. The proposed densitometric method was validated in accordance with International Conference on Harmonization guidelines [(ICH) Q2 (R1)]. The developed and validated densitometric method can be applied for routine quality control of Tolperisone Hydrochloride and Paracetamol in combined tablet dosage form.