ABSTRACT

New simple, sensitive, economical UV and RP-HPLC methods were established for evaluating the therapeutic dosage forms of linagliptin and dapagliflozin propanediol monohydrate. Ethanol was utilized as solvent for first-order derivative UV spectrophotometric analyses. The method involves conversion of zero order spectra into first-order spectra with delta λ8 and scaling factor 4. A rapid RP-HPLC method was developed using an isocratic mobile phase comprising 65:35% V/V acetonitrile and water (pH 3 using orthophosphoric acid) at a flow rate of 0.7 mL min-1 over Phenomenex Luna 5µ C 18 (2)100 Å (150×4. 6 mm× i.d. 5 µ) column at ambient temperature with UV detection at 225 nm. The results of validation studies were in compliance with ICH guidance. In addition, forced degradation studies of drugs have been performed via the developed methods. Both of these recently created techniques could be used in the regular pharmaceutical analysis of these medications.