DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHIC METHOD FOR SIMULTANEOUS ESTIMATION OF METFORMIN HYDROCHLORIDE AND TENELIGLIPTIN HYDROBROMIDE IN COMBINED DOSAGE FORM

Abstract

The stability indicating High performance thin layer chromatographic method was developed using Camag HPTLC system. The separation was carried out using Silica G60 F254precoated TLC plates used as stationary phase. The mobile phase used was Toluene: Methanol: GAA: TEA (540.50.5). Densitometric analysis was carried out in the absorbance mode at 257 nm. A well resolved peaks were obtained for MET and TENE at Rf 0.57 and 0.79 respectively. The calibration curves show linearity in the concentration range of 300-800ng and 7.5–20 $\mu$ g band for MET and TENE with correlation coefficients of 0.993 and 0.992 respectively. Degradation study of both drug were carried out in acidic, alkaline, Thermal, oxidation, photolytic conditions. Degraded products peaks were also well resolved. The developed method was validated as per ICH guidelines in terms of linearity, accuracy, precision, limit of detection, limit of quantification. The developed HPTLC method was simple, accurate and precise and used for the quantitative analysis of drug in the presence of their degradation products.