Development of simple, reliable, rugged, specific and sensitive analytical methods for quantification of impurities in drugs like Proton Pump inhibitors

Abstract

Drug analysis play very important role in creating the basis for high efficient drug therapy by giving analytical support to synthetic, biotechnological, pharmacological, pharmaceutical technological , clinical research to find the most efficacious drug material and its optimal dosage form. Impurity profiling can be defined as a group of analytical activities aiming at identification/structural elucidation and quantitative determination of organic and inorganic impurities as well as residual solvents in bulk drugs and pharmaceutical formulations. The DMF (Drug Master File) holder or the ANDA(Abbreviated New Drug Application) applicant should summarize those actual and potential impurities most likely to arise during synthesis, purification and storage of the drug substance. This summary should be based on sound scientific appraisal of chemical reactions involved in the synthesis and impurities associated with raw materials that could contribute to the impurity profile of the drug substance and also about possible degradation products. The studies (e.g. NMR,IR and MS) conducted to characterize the structure of actual impurity or degradation product present in the drug substance at the apparent level of 0.1% or above(calculated using the response factor of drug substance) should be described.