Development and Validation of Stability Indicating RP –HPLC Assay Method For Linagliptin and Metformin Hydrochloride In Extended Release Tablet

Abstract

The aim of current research work was to develop a validated simple and precise stability indicating RP-HPLC method for determination of linagliptin and metformin HCL in extended release dosage form. Chromatographic separation of linagliptin and metformin HCL was obtained on zorbax SB phenyl (150x4.6) mm 5µm column using mobile phase containing buffer (1-0ctane sulphonic acid sodium salt anhydrous buffer): ACN for linagliptin (65:35) and for metformin HCL and flow rate was optimized at 1.2 mL/min. Detection and quantification was done at wavelength maxima for linagliptin 294 nm and metformin HCL 232 nm using a UV detector. Linear relationship was observed in linagliptin method for concentration range 17.5-32.5 µg/ml and for metformin HCL 48.0-81.0 µg/ml with correlation coefficient of 0.9996 for both linagliptin and metformin HCL. Different stress conditions were applied on the developed method such as acidic hydrolysis, basic hydrolysis, oxidation, thermal and photo degradation and degradation product has been found during the estimation of linagliptin and metformin HCL. Developed method has not shown any interference during different stress conditions. The method for analysis of linagliptin and metformin HCL was found to be accurate and precise with average recovery 97.0%-103.0% and %RSD for all parameters of chromatographic system were found to be not more than 2.0%. The proposed method was found suitable for the routine quantitative analysis of linagliptin and metformin HCL in extended release tablet.