A simple and sensitive stability-indicating RP-HPLC assay method for the determination of aceclofenac.

The aim of the present study is to develop a stability-indicating assay method for the determination of aceclofenac after being subjected to different International Conference on Harmonization prescribed stress conditions, such as hydrolysis, oxidation, heat, and photolysis. Aceclofenac (2-[2-[2-(2,6-dichlorophenyl)aminophenyl]acetyl]oxyacetic acid) is decomposed under hydrolytic stress (neutral, acidic, and alkaline) and also on exposure to light (in solution form). The compound is stable to oxidative stress, heat, and photolytic stress (in solid form). The major degradation product is diclofenac, which is confirmed through comparison with the standard. Separation of the drug from major and minor degradation products is achieved on a C-18 column using methanol-0.02% of ortho phosphoric acid in a ratio of 70:30. The method is linear over the concentration range of 17-100 microg/mL (r(2) = 0.9988). The detection wavelength is 275 nm. The method is validated for linearity, range, precision, accuracy, specificity, and selectivity.