Stability indicating HPLC-Fluorescence detection method for the simultaneous determination of linagliptin and empagliflozin in their combined pharmaceutical preparation

A sensitive, accurate, and precise liquid chromatographic method has been developed validated for the determination of Linagliptin (LNG) Empagliflozin (EMP) in their combined tablets. Chromatographic separation was carried out on ODS-3 Inertsil® C18 column (150×4.6 mm, 5 µm). The mobile phase (consisting 0.30% Triethyl amine buffer (TEA) at pH = 4.5, adjusted using ortho-phosphoric acid); B acetonitrile) pumped through whose temperature maintained 40 °C, with a flow rate 1.7 mL/min, gradient elution from 0-3 min A:B (75:25, v:v), then 3-6 ratio changed to be (60:40, v:v). Fluorescence detection (FLD) performed 410 nm after excitation 239 nm. Acceptable linearity, accuracy precision values proposed were found over concentration ranges 0.5-15 µg/mL LNG 1.0-30 EMP correlation coefficients 0.9997 0.9998 case EMP, respectively. recoveries relative standard deviations percentages following ranges: 98.56-101.85 0.53-1.52% 98.00-101.95 0.31-1.05% EMP. quantification limits 0.15 0.45 0.22 0.67 optimized proved specific, robust, accurate reliable drugs pure form or pharmaceutical preparations. No significant difference regarding upon statistical comparison between obtained results those reported method. Furthermore, is stability-indicating assay exposure studied variable forced degradation parameters, such as acidic, alkaline oxidative conditions, according recommendations International Conference Harmonization guidelines. simplicity selectivity allows its use quality control laboratories.