METHOD DEVELOPMENT, VALIDATION AND STABILITY INDICATING ASSAY FOR TENELIGLIPTIN HYDROBROMIDE BY RP-UFLC

The study aimed to develop a specific, exact, selective, precise and accurate Reversed Phase Stability Indicating Ultra-fast Liquid Chromatography (RP-UFLC) strategy is created and validated for Teneligliptin hydrobromide in the pure and marketed formulation. The method showed an adequate separation for Teneligliptin hydrobromide from their degradation products. The chromatographic separation was accomplished on Phenomenex Kinetex C18 (250 × 4.6 mm) with the mobile phase of methanol, acetonitrile, and potassium dihydrogen orthophosphate (40:20:40 v/v/v). The pH is changed by 4.6 using orthophosphoric acid. The run time was 10 min and the retention time of drug is 3.3 min. The detection is carried out at 246 nm using photodiode array detector (PDA) and ultraviolet (UV) with a flow rate of 1.0 ml/min. The drug product is exposed to acid and base stress, photolytic stress, Thermal stress, oxidative stress, and hydrolytic stress conditions, and the stressed samples were analyzed by the proposed method. The linearity of the proposed strategy is researched in the range of 2-10 µg/mL (r² = 0.9915). The present method was validated concerning system suitability, accuracy (recovery) precision, linearity, limit of detection (LOD) and limit of quantification (LOQ) and robustness according to the ICH Guidelines.