The stability of aceclofenac under stress conditions was assessed to identify the degradation products. So, it was subjected to stress conditions like acid, base and oxidation, according to ICH guideline Q1A (R2). One degradation product formed when the drug was subjected to acid stress. Three degradation products were formed during the basic stress condition. The drug substance was found to be stable to oxidative stress. The degradants formed during the stress were separated on a C-18 column using gradient preparative HPLC elution. The only product (DP-2) formed during the acid stress and this one is same as of one of the three degradation products (DP-1, DP-2, DP-3) were formed during base stress. 1D and 2D NMR spectra and mass spectral analysis supported the proposed structures for the products. The products DP-2 and DP-3 have been reported earlier but this is the first report of product DP-1 as a degradation product of aceclofenac.

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Finasteride is a 5-α-reductase inhibitor with a steroidal skeleton and an amide group in its structure. It was subjected to forced degradation to observe its stability under stress conditions according to ICH guidelines. It was found to be stable to base and peroxide. However, in acid medium, three degradation products were observed. All of them were isolated from the reaction mixture by preparative HPLC. Their structures were elucidated by extensive analysis of 1D, 2D NMR spectra and HRMS. To best of our knowledge, none of them have been reported elsewhere.

To in-line with the ICH guideline Q1A(R2), Itraconazole was subjected to acidic ,basic and oxidative stress . Drug was stable in all the conditions except oxidation stress. Separated the two oxidative degradation products, by using gradient elution, C8 column on preparative HPLC and structural elucidation was performed by using 1D & 2D NMR spectroscopic studies and mass analysis. Those are recognized as 1-( 4-5-oxo-1,5-dihydro-4H-1,2,4-triazol-4-yl)phenyl) piperazine 1oxide (DP-2).These degradents are innovative impurities which are found first time in this product. Moreover, the degradation mechanism from Itraconazole to DP-1 and DP-2 was also proposed.