Determination of traces of crystalline cefuroxime axetil content in cefuroxime axetil amorphous drug substance using powder X-Ray Diffraction (PXRD) Technique

Amorphous materials are often preferred in the pharmaceutical industry due to their enhanced dissolution rate and bioavailability. Since the amorphous state is metastable and less thermodynamically stable relative to the crystalline state, there is always the potential for unexpected crystallization during storage. Conversion of amorphous to crystalline state can be evaluated by stability studies. Accurate quantification of crystalline phases present in drug materials has become increasingly imperative, due to stringent regulatory concerns about polymorph characterization. In the present study, a quantification method was developed for the determination of Crystalline phase in Cefuroxime Axetil amorphous phase using X-ray powder diffraction technique. Validation of quantification method was carried out with respect to Specificity, Precision, Linearity, Robustness, Limit of Detection and Limit of Quantification. Validation results were found to be within acceptance criteria.