NOVEL UV AND RP-HPLC STRATEGIES FOR SIMULTANEOUS QUANTIFICATION OF DAPAGLIFLOZIN AND GEMIGLIPTIN IN SYNTHETIC MIXTURES

Abstract

A novel analytical approach was developed for the simultaneous estimation of gemigliptin and dapagliflozin in synthetic mixtures, employing both UV spectrophotometry and reverse-phase high-performance liquid chromatography (RPHPLC). The UV spectrophotometric method utilized a simultaneous equation approach with a Shimadzu UV-1700 Spectrophotometer, analyzing absorbance in methanol at 248.4 nm for gemigliptin and 224 nm for dapagliflozin over linear ranges of 50–250 μg/mL and 10–50 μg/mL, respectively. For RP-HPLC, a C18 column (250 × 4.6 mm, 5 μm) with a mobile phase of acetonitrile, methanol, and ammonium acetate buffer (pH 5.5; 60:20:20 %v/v/v) at 1 mL/min flow rate and detection at 268 nm achieved optimal separation. Retention times were observed at 4.403 min for gemigliptin and 8.328 min for dapagliflozin. Both methods demonstrated excellent linearity (r² = 0.9992– 0.9999), precision, accuracy, specificity, and robustness as per ICH Q2(R1) guidelines. The combination of these techniques allows rapid, sensitive, and reliable quantification of both compounds in synthetic mixtures, supporting routine quality control applications