Stability-Indicating Analytical Method Development and Validation of Thiocolchicoside and Ibuprofen in Tablet Dosage Form by RP-HPLC Method

Objective: First time, a simple, specific, accurate and economic stability-indicating reverse phase high performance liquid chromatographic method was reported for the simultaneous estimation of THIO IBU in tablet dosage form. Method: The has shown adequate separation from their degradation products. Separation achieved on an Inertsil, 3V ODS C18, 4.6 mm x 250 mm, 5μ column at wavelength 248 nm, using mobile Methanol: Dist. water (50:50, v/v) mode isocratic elution flow rate 1.0 ml/min. Results: This results minimum retention time i.e. 2.317 1.075 min. correspondingly, which gives fast separations drugs furthermore both drug combinations are subjected to acidic, base, oxidation, thermal photolytic stress environment. Thus stressed samples these analyzed by proposed analytical method. Quantitation achieve with UV detection nm based peak area linear calibration curve concentration range 100-600 ppm 400-2400 IBU. LOD's found 2.00 0.54 addition that LOQ's were be 6.08 1.63 resp. Conclusion: statistical analysis proved this novel established accurate, precise study do not shows interfering peaks degrades excipient. is therefore suitable purpose quality-control laboratories quantitative individually combined form, as it performed validated per ICH Q2 (R1) Q1A (R2) guideline meets specific acceptance criteria.
 Keywords: Thiocolchicoside (THIO), Ibuprofen (IBU), RP-HPLC, Stability-indicating, ICH.