Application of a stability-indicating tlc method for the quantitative determination of dexketoprofen trometamol in pharmaceutical dosage forms

摘要

Objective: A sensitive, selective, precise and stability-indicating thin layer chromatographic method for analysis of Dexketoprofen trometamol, both as a bulk drug and in formulation, was developed and validated. Method: The method employed TLC aluminum plates precoated with silica gel 60F- 254 as the stationary phase and the solvent system consisted of toluene:ethyl acetate:glacial acetic acid (6:2:0.2v/v/v). This system was found to give compact spots for Dexketoprofen trometamol (Rf value of 0.450.02). Dexketoprofen trometamol was subjected to acid and alkali hydrolysis, oxidation, photo, and neutral degradation. Result: The peak of the degradation product was well-resolved from the pure drug and had significantly different Rf value. Densitometric analysis was carried out in the absorbance mode at 255nm. The method was validated for precision, robustness, and recovery. Conclusion: As the method can separate the drug from its degradation products, it can be used to monitor stability.