DEVELOPMENT AND VALIDATION OF A STABILITY-INDICATING RP-HPLC METHOD FOR THE DETERMINATION OF EMPAGLIFLOZIN IN BULK AND PHARMACEUTICAL DOSAGE FORMS

Abstract

For the simultaneous measurement of empagliflozin in pharmaceutical formulations, a quick,
sensitive, and precise reverse-phase high-performance liquid chromatography (RP HPLC)
technique was created and approved. A C18 was used to accomplish the chromatographic
separation. Column (250 mm × 4.6 mm, 5 μm) with a mobile phase of 95% acetonitrile and
0.5% water (95:05 v/v) at a flow rate of 0.5 mL/min. Empagliflozin was detected at 254 nm with
retention periods of 4.75 and 6.77 minutes, respectively. The technique showed linearity for
both medications throughout concentration ranges of 5 to 30 ppm with correlation values greater
than 0.999. ICH recommendations for accuracy, precision, specificity, linearity, robustness, and
stability were used to validate the developed method. For both analytes, recovery experiments
revealed mean recoveries of 0.99.67%. With RSD values, the approach demonstrated good
precision.