A QUALITY BY DESIGN (QbD) ASSISTED RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF LINAGLIPTIN AND DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE IN TABLET DOSAGE FORM

ABSTRACTObjective: Linagliptin and Dapagliflozin Propanediol Monohydrate in tablet formulations weresuccessfully isolated and measured using a rapid, precise, sensitive, and reliable RP-HPLC technique.The optimization process makes use of a Quality by Design (QbD) methodology. The separation ofchromatogram was performed with a JASCO HPLC (model PU2075 Plus) with a UV-200 Plus detector.A Qualisil 5 BDS C8 (250 × 4.6mm, 5 μm particle size) column were used in isocratic conditions. TheMobile phase is used in ratio of 50:50%v/v (ACN: OPA) and pH was adjusted to 3.5 usingTriethylamine 1.0ml/min will be the flow rate, 20ul will be an injection volume and 230nm is aWavelength, resulting 8min will be the total run time. Linagliptin’s retention duration was 2.783minutes, were as Dapagliflozin Propanediol Monohydrate's was 4.925 minutes. Linagliptin as well asdapagliflozin propanediol monohydrate have linearity ranges of 5,10,15,20 and 25μg/ml and 10,20,30,40and 50μg/ml, respectively, with correlation coefficients (r2) of 0.9994 and 0.9991. For both drugs, thepercentage recovery varied between 99.92% and 99.98%. The drug contents were 99.9% w/w forlinagliptin and 99.91% w/w for dapagliflozin propanediol monohydrate, according to the assay results.With intraday or interday precision showing an average relative standard deviation (%RSD) of less than2%, the approach demonstrated good reproducibility. The method's robustness evaluation shows that it isunaffected by even minor variations in the chromatographic settings. In conclusion, this QbD-assistedRP-HPLC method is straightforward, highly specific, rapid, and trustworthy, making it appropriate forroutine quality control assessments.