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

Abstract

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