Quantification of amorphous phase by gravimetric vapor sorption

In the envisaged study, heat induced crystalline to amorphous phase generation and amorphous content quantification in crystalline form of Pantoprazole sodium sesquihydrate drug substance was studied by different analytical techniques like variable temperature Powder X-Ray diffraction (VT-PXRD), Thermo gravimetric Analysis (TGA) and Gravimetric vapor sorption analyzer (GVS). Amorphous Pantoprazole Sodium is obtained by dehydrating Pantoprazole Sodium sesquihydrate. Amorphous and Crystalline contents are varied to obtain different concentrations of Amorphous in Crystalline phase. The slope of the vapor sorption curves of the samples found to be characteristic to the concentration of amorphous phase. Linearity with a good correlation has been established between concentration of amorphous phase and slope of the sorption curve, the same linear equation has been used for cross-predictions and the results are found to be satisfactory.