Development and validation of stability indicating assay methods for estimation of anti diabetic drugs

Abstract

newline The research study demonstrates development and validation of stability indicating HPLC, HPTLC methods and analytical UV methods for Anti diabetic drugs, degradation kinetic study and identification of degradation product.Literature review revealed few analytical methods i.e. HPTLC, HPLC, stability indicating HPTLC, stability indicating HPLC and UV spectrophotometric for an individual drug and in combination with other drugs. However, the reported analytical methods are not adequate to monitor degradation kinetics and to demonstrate the degradation pattern of the drugs in various stress conditions. To estimate selected drugs (Alogliptin, Teneligliptin and Dapagliflozin-Metformin combination) stability indicating HPLC/ HPTLC methods were developed and validated as per ICH guidelines. The developed methods for Alogliptin and Teneligliptin were extended to study degradation kinetics of drugs with different stress conditions. Further, acid degradation product of Alogliptin was isolated and identified by IR, NMR and MS analysis. The developed methods were found to be accurate, precise, simple, sensitive and stability indicating and are suitable for routine analysis of drugs in their formulations. Order of degradation reaction, degradation rate constant, half-life and shelf life were also calculated. Moreover, two UV methods (dual wavelength and first order derivative method) were developed and validated for Teneligliptin-Metformin combination.This Ph.D. thesis would be useful for providing stability indicating HPLC and HPTLC methods and UV method for routine analysis of selected anti-diabetic drugs and they can be extended for bio-analysis of drugs. newline