Analytical method development and validation of empagliflozin via RP-HPLC and UV spectrophotometric technique
Abstract
Background: In the present study, UV spectrophotometry and reverse-phase high-performance liquid chromatography (RP-HPLC) were utilised to develop and validate a quantitative determination of empagliflozin, followed by its estimation in pharmaceutical dosage forms. Methods: The design of experiment (DoE) was used to optimise RP-HPLC method for improved accuracy and precision. Similarly, for UV spectrophotometry, phosphate buffer pH 7.4 was selected as solvent. Reverse-phase elution was employed to achieve efficient chromatographic separations using a Shimadzu HPLC C18G column (250×4.6 mm). The mobile phase used for RP-HPLC is composed of acetonitrile: methanol: ortho-phosphoric acid in the ratio 50:20:30 v/v at flow rate of 1.0 mL/min. Furthermore, investigations on forced degradation were conducted to demonstrate stability of technique. ICH guidelines were followed in validation of established procedures. Results: The detection was carried out within the range of 200-400 nm, revealing an absorption maximum at 223 nm. The linearity range for empagliflozin was 4-14 µg/mL with a correlation coefficient of 0.9930. The retention time was found to be 3.38 min with a linearity range of 10-60 ppm and a correlation coefficient of 0.9966. The statistical validation of evolved methods was conducted to assess linearity, precision, accuracy, robustness, ruggedness, and detection, further subjecting system to hydrolytic, oxidative, photolytic, and thermal degradation stress conditions.…
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