A validated stability-indicating gas chromatography method for determination of divalproex sodium impurities in pharmaceutical preparation.

A stability-indicating gas chromatography (GC) method has been developed and validated for the quantitative determination of divalproex sodium impurities in pharmaceutical preparation. A technique has been developed whereby the peak purity of a compound with poor UV detection can be determined using a gas chromatograph coupled with a mass spectrometer. The drug products were subjected to hydrolysis, oxidation, photolysis, and heat to apply stress conditions.