Department of Pharmaceutical Chemistry, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru-570015, Karnataka
An accurate and lively LC-MS/MS and NMR analytical methods have been developed for recognition and characterization of key impurities in Teneligliptin. Teneligliptin is an anti-diabetic drug used to treat Diabetes mellitus Type II and three unknown impurities were detected in Teneligliptin bulk drug substance using RP-UFLC method at RT 4.02 min, 5.09 min and 6.2 min. These impurities were isolated by preparative HPLC and further characterized by using LC-MS/MS and NMR techniques. LC-MS/MS analysis was performed using C18 reverse phase column and with Methanol and Ammonium Formate (80:20) as a mobile phase. The flow rate was maintained at 0.5mL/min with injection volume as 10 μL. The separations were achieved with binary gradient program and the column is maintained with ambient temperature. The MS conditions adopted for this analysis with scan range of m/z = 50 to 500 with dwell time 3 seconds. NMR was carried out using DMSO as solvent. Based on spectral data, the impurities have been characterized as IMP 3, IMP 5 and IMP E.
Teneligliptin, LC-MS/MS, Diabetes mellitus, DMSO and Preparative HPLC, NMR
