The objective of a recent investigation was to develop an RP-HPLC technique for assessing empaglifl ozin in both bulks and pharmaceutical dosage forms. An Agilent Eclipse XDE C-18 (4.6 mm x 250 mm, 5.0 m particle size) column for separation, a mobile phase of 0.1 M TEA pH 5.5 corrected by methanol and OPA in a proportion of 4:96 percent v/v at a fl ow rate of 0.7 mL/minwas utilized towards achieving the desired peak resolution. Diagonal array detectors (DADs) are utilized to measure the eluent at a wavelength of 270 nm. The regression equations for empaglifl ozin in bulk were y = 58.924x-5.693 and the regression equations for empaglifl ozin in tablet dosage form were y=57.927x+5.027. The calibration curve shows that the peak size was proportionate toward the concentration. In the precision study, the % of the amount was found in the 100 to 101% range. In %accuracy, %RSD was found to be 99.18 to 99.84 for empaglifl ozin in bulk and 99.29 to 99.53 for empaglifl ozin in the tablet dosage form. The limit of detection (LoD) for empaglifl ozin was determined to be 0.309143 μg/mL, while the limit of quantitation (LoQ) was determined in the direction of 0.936798 μg/mL. Based on the fi ndings of the robustness experiments, it was determined that the method’s accuracy and specifi city remain within acceptable ranges when subjected to minor adjustments to fl ow rate, wavelength, and mobile phase. The established technique was suitable for use in quality control labs to determine the quantity of empaglifl ozin present in bulk and tablet formulation

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.