RP-HPLC Method Development and Validation for the Estimation of Trelagliptin in Pure and Pharmaceutical Dosage Form

An accurate, sensitive, precise, simple isocratic reverse phase HPLC (RP-HPLC) method has been developed and validated for quantification of Trelagliptin in bulk and pharmaceutical tablet dosage forms. With acetonitrile as the organic solvent, the best separation was achieved on a 250 mmx 4.6 mm i.d, 5µ-particle size Inertsil®-Octadecyl-silyl-3V-Reverse-Phase-C18-column with 0.02M Dipotassium hydrogen orthophosphate in water pH: 2.5 with Orthophosphoric acid: Acetonitrile (40:60v/v) in the isocratic mode of elution as mobile phase solvent at a speed of 1.0 ml/ min. UV detection was at 210 nm. Retention time of Trelagliptin was 12.8 minutes. With a correlation coefficient of about 0.9974, peak-response was obtained as function of concentration over the range of 80 to 240 µg/ ml forTrelagliptin.Trelagliptin was shown to have a percentage assay of 110.89 %.Trelagliptin had a limit of detection (LOD) of 0.2 µg/ mL and a limit of quantification (LOQ) of 0.6 µg/ ml.The presence of excipients in the formulation Zafatek had no effect on the assay method.The procedure is appropriate for use in QC-laboratories since it is economical and precise.