Spectrophotometric Method Development and Validation of Empagliflozin in Active Pharmaceutical Ingredient and Tablet Dosage Form

Abstract

Empagliflozin, an inhibitor of SGLT-2, a sodium glucose co-transporter is found mainly in the proximal tubules of the nephronic components of the kidney. The assay of empagliflozin in its tablet form has been created using a unique, secure, and sensitive UV-spectrophotometric approach. During the development and validation of the method for the assay of empagliflozin, methanol was employed as the solvent. The maximum absorbance wavelength of the solution was determined by scanning in a UV spectrophotometer. At the specified wavelength; absorbance was measured using a variety of calibration standards. The linearity and range of the calibration curve of concentration vs. absorbance were computed. The accuracy, precision, limit of detection, limit of quantitation, and ruggedness of the analytical approach were among the metrics that were determined. A correlation coefficient of 0.999 indicated linearity within the concentration range  2–10 µg/mL. The maximum absorbance of empagliflozin in methanol was determined to be 238.5 nm. Recovery was estimated as per International Conference on Harmonization guidelines and was found to be as per the acceptance limits: 93.25%. The developed UV method was found to be precise with relative standard deviation less than 2%. The assessment of empagliflozin in its tablet formulation using a UVspectrophotometric technique was determined to be both safe and helpful. The uniqueness of this research is based on a costefficient, time-saving, safe, easy, and successful approach for validating empagliflozin.