Stability-indicating HPTLC method for simultaneous determination of Drotaverine and Aceclofenac in tablet formulation

摘要

A sensitive, selective, precise and stability indicating high-performance thin-layer chromatographic method for quantification of Drotaverine and Aceclofenac in pharmaceutical dosage form has been established and validated. The method employed TLC aluminium plates precoated with silica gel 60F254 as stationary phase and the solvent system consisted of Ethyl acetate: Benzene: Methanol: Glacial acetic acid (0.5:7:2:0.5 v/v/v/v) as mobile phase. Densitometric analysis of drugs was carried out in absorbance mode at 242 nm. The Rf values was found to be 0.24 for DRT and 0.76 for ACE. The linear regression analysis data for the calibration plots showed good linear relationship over the concentration range of 300–1800 ng per band (correlation coefficient r2=0.9955) for aceclofenac and (correlation coefficient r2=0.9930) for drotaverine, respectively. The method was validated for accuracy, precision, ruggedness, and robustness. The limits of detection and quantification were 15.00 and 45.46 ng per band, respectively, for aceclofenac and 222.70 and 674.84 ng per band, respectively, for drotaverine. The method was validated as per ICH guidelines. Stability studies were performed by forced degradation of tablet sample with acid and base hydrolysis, oxidation, dry heat and UV-induced degradation. Peaks of the degraded products were well resolved from the pure drugs. As the method could effectively separate the drugs from their degradation products, it can be used as a stability indicating method.