Since the discovery of gliptins, a dipeptidylpeptidase-4 (DDP-4) inhibitors, a number of structural modifications have been made in order to increase the antidiabetic activity. These DDP-4 inhibiters (vildagliptin, sitagliptin and linagliptin) showed better glycemic control when given along with metformin. Few analytical methods are reported for simultaneous determination of metformin and gliptins. But, no rapid method is yet reported for simultaneous determination of metformin, sitagliptin, vildagliptin and linagliptin using single analytical procedure with same mobile phase. Development of single analytical procedure has an advantage of analyzing all drugs alone or in combination using same column and single mobile phase.Hence, a rapid, sensitive and reliable HPLC method was developed for the simultaneous determination metformin and three gliptins (vildagliptin, sitagliptin and linagliptin) in combined formulations. The separation was performed on fast monolithic column using isocratic, ion-pairing mobile phase consisting of mixture of 10 mM sodium dihydrogen phosphate(32%), 10 mM Sodium dedosyl sulphate(32%) and acetonitrile (36%). The flow rate was set at 2.5ml/min and the analytes were monitored by setting UV wavelength at 208 nm while analyzing metformin, vildagliptin and sitagliptin and at 228nm while analyzing metformin and linagliptin at 30OC . The newly developed method was validated according to ICH guidelines and also applied for stability studies on linagliptin tablets. The calibration curves were linear (r2>0.998) over a concentration range 5-400 �g/ml for metformin, 1-10 �g/ml for vildagliptin & sitagliptin and 0.25-2.0 �g/ml for linigliptin. All three tablet formulations were routinely assayed with accuracy and precision and without interference from excipients. The method is also stability indicating with respect to linagliptin.

Simultaneous determination of metformin and three gliptins in pharmaceutical formulations using RP HPLC: Application to stability studies on linagliptin tablet formulation

247th National Meeting (2014)

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