Development and Validation of Analytical Method for Linagliptin Drugs in Pharmaceutical Dosage form by RP-HPLC

Abstract

The objective of the current research was to develop and validate the reversed-phase high performance liquid chromatography (RP-HPLC) method for linagliptin from formulation and bulk material. The development was performed on C18 stainless steel column using 0.1 M TEA pH 5.5 adjusted with OPA and methanol (30:70% v/v) at 0.7 mL/min fl ow rate. Samples were analyzed by 1024 DAD detector at 238 nm. The developed method complied with the system suitability study with acceptable asymmetric factor and number of theoretical plates. The linearity was observed between 10–50 μg/mL concentrations (R2 = 0.999). The mean %recovery of 99.33 to 99.88% with %RSD between 0.13 to 0.24 was observed. The drug content was found within the acceptable limit in interday and intraday precision study. The method was fond robust and small changes in fl ow rate, mobile phase and wavelength did not hamper the accuracy and specifi city of the method and all results were found within acceptable limit. Limit of detection (LoD) and limit of quantitation (LoQ) of 0.17854 and 0.54105 μg/mL, respectively, were observed. This research confi rmed the development of simple, robust, sensitive, accurate and cost-eff ective methods that can be used to analyze Linagliptin using RP-HPLC from tablet and bulk dosage.