NEW VALIDATED STABILITY-INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS DETERMINATION OF METFORMIN HYDROCHLORIDE, LINAGLIPTIN AND EMPAGLIFLOZIN IN BULK AND PHARMACEUTICAL DOSAGE FORMS

Objective: The purpose of the present study is to develop simple, fast, accurate, precise, and robust stability-indicating reverse phase high-performance liquid chromatographic (RP-HPLC) method for simultaneous determination metformin HCl, empagliflozin, linagliptin in their combinations. Methods: Separation was performed on Agilent Eclipse XDB-C18 (250 mm x 4.6 mm, 5 µm) column with a mobile consisting 0.1 % triethylamine (pH =3) buffer acetonitrile ratio 40: 60 (v/v) at flow rate 1 ml/min. Detection analytes carried out wavelength 240 nm photodiode array detector. developed validated as per International Conference Harmonization (ICH) guidelines. Results: retention time values under optimized condition were 2.660 min, 3.586 5.412 min linagliptin, respectively. linear over concentration range 100 µg/ml-1500 µg/ml, 0.5 µg/ml-7.5 2.5 µg/ml-37.5 µg/ml HCl,linagliptin empagliflozin limit detection (LOD) found be 4.00 0.02 1.00 degradation peaks clearly resolved from parent drug chromatograms forced studies. Conclusion: successfully applied combined tablet dosage forms hence can used routine quality control drugs pharmaceutical bulk, forms.