Method Development, Validation and Stress Degradation Study of Teneligliptin by RP-HPLC

[摘要] To develop and validate simple, rapid, linear, accurate, precise and economical reverse phase-highperformance liquid chromatography (RP-HPLC) method for of stress degradation study of Teneligliptin. The separation and quantization were achieved on Inertsil C18(250 mm × 4.6ID,5 um ). The mobile phase selected was Methanol: Water (90:10) at a flow rate of 0.8 ml/min and detection of analytes was carried out at 248nm at pH 3. The method exhibited good linearity over the range of 10–50 µg/mL. The drug is freely soluble in organic solvents Methanol. The drug was identified in terms of solubility studies and on the basis of melting point done by capillary tube method. The drug which when subjected to thermal, photolytic, oxidative, and acidic stress degraded into many degradation products. In most of the cases, the degradation rate was seen to be directly proportional to the amount of stress applied. The thermal stress was increased by increasing the incubation temperature, the faster the degradation took place. The values of LOD were found to be 0.956 ug/ml for TNG and the calculated LOQ values were found to be 0.171 ug/ml.

[学科分类] 药学

[关键词] RP-HPLC;Validation;Methanol;Teneligliptin;Force degradation