Green Spectrophotometric Method for the Determination of Empagliflozin in Tablets in Syrian Market

Abstract

Introduction: visible and ultraviolet spectroscopy is considered a simple and specific analytical method; therefore, it is widely used in many fields. Empagliflozin has recently been used in the treatment of Type II diabetes mellitus, it is classified as a sodium glucose cotransporter-2 inhibitor (SGLT-2 I), but so far it has not been included in the Pharmacopoeias. A published analytical method for the determination of empagliflozin in bulk and pharmaceutical dosage has been validated but with modification to the solvent used and its quantity to enhance the greenness of the method, depending on its UV absorption, due to the existence of chromophore groups in its chemical structure. The greenness of the method was assisted by AGREE and Eco-scale tools.

Materials and methods: This method depends on the measurement of empagliflozin based on its UV absorption at 223 nm wavelength. The effect of the used solvent was also investigated to get the best results.

Results: The analytical method showed a linear relationship between absorbance and concentration in the range of (4-20 ppm), with a linear regression correlation coefficient of R2=0.9998. The precision of the method (RSD <2%), and accuracy were determined as recovery which values ranging between 100.01-99 .78%, the detection limit (LOD) is 0.295 ppm, and the quantitation limit (LOQ) is 0.894 ppm. Empagliflozin was successfully determined in its pharmaceutical forms (tablets), based on the studied method, and it was found to be specific and selective, with no response or interference from the excipients in pharmaceutical forms at the desired wavelength, with recovery values ranged between 102.52-98.09%. The used method is greener and eco-friendlier than the published HPLC method.

Conclusions: Empagliflozin has been successfully determined as a raw material and in its pharmaceutical forms in the local market based on its UV absorption using a green analytical method.

Keywords: Empagliflozin, Diabetes Mellitus, Uv Region, Spectrophotometer, Validation, Greenness Assessment.