RP-HPLC Method Development and Validation for an Estimation of Empaglifl ozin from Bulk and Pharmaceutical Dosage Form

Abstract

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