Development and Validation of Stability Indicating RP-HPLC method for Teneligliptin Hydrobromide Hydrate
Girish D. Dahikar*, Gayatri Bobade
Institute of Pharmaceutical Education and Research, Borgaon (Meghe), Wardha (Maharashtra state), India
Teneligliptin hydrobromide hydrate is a new FDA approved drug for treatment of Diabetes Mellitus. Very few methods have been reported for its identified degradation products and their effects on human. A simple, rapid, precise and accurate stability indicating RP-HPLC method was developed and validated for identification of Teneligliptin hydrobromide hydrate and its degradants on Kromacil C18 column using pH 5.5 phosphate buffer and methanol (75:25v/v) as a mobile phase in isocratic mode of elution at a flow rate 1.2 ml/min. The column effluents were monitored by a variable wavelength UV detector at 270 nm. The method was validated as per ICH guidelines. Forced degradation studies of Teneligliptin hydrobromide hydrate were carried out under acidic, basic, neutral, peroxide, photo and thermal conditions. Degradation was observed in basic and neutral stress samples, but not in acid, peroxide, photo and thermal stress samples.
Keyword: Teneligliptin hydrobromide hydrate, RP-HPLC, validation, stability, degradation