A Rapid RP-HPLC Method Development and Validation for the Analysis of Linagliptinin Bulk and Pharmaceutical Dosage Form

A simple, precise, accurate and robust RP-HPLC-UV method was developed and validated for the determination of Linagliptinin tablet dosage forms. Reverse-phase chromatography was performed on Agilent (100 mm × 2.5 mm, 3μm) column of C18 HPLC with EZ Chrome software with UV detector. Methanol: water containing 0.1% ortho phosphoric acid (70:30) (v/v) was used as mobile phase at a flowrate of 0.8 mL min^-1 with UV detection at 296 nm. Linearity was observed in the concentration range of 2.5- 15 μg mL^-1 with correlation co-efficient (R² = 0.999). The method was validated as per ICH guidelines. The RSD for intra-day (0.254) and inter-day (0.2449) precision were found to be less than 2 %. The percentage recovery was in good agreement with the labelled amount in the pharmaceutical formulations and the method is simple, precise, accurate and robust for the determination of Linagliptinin pharmaceutical dosage forms.