HPLC method development for the analysis of linagliptin

Abstract

The purpose of this study was to develop a reliable, rapid and sensitive method based on high performance liquid chromatography (HPLC) for the determination of an anti-diabetic drug linagliptin in its pure form as well as in its pharmaceutical dosage forms. Different chromatographic conditions were investigated to optimize the parameters for the established method. In this study, the chromatographic assay involved the use of C18 column (150×4.6mm, packed with 5 μm particles) as the stationary phase and a combination of methanol: phosphate buffer (of pH 4.5) as the mobile phase at a ratio of 70:30 v/v pumped at a flow rate of 1mL/min in isocratic mode. The total run time was 10 min with a retention time of 3.3 min. The detection wavelength was 241 nm. Five marketed products of linagliptin were assayed by this developed method and their potency were calculated successfully, the results of which demonstrated both the feasibility and reliability of this method for the quantitation and qualification of linagliptin in pharmaceutical dosage forms as well as in its pure form.