Stability indicating RP-HPLC Method Development and Validation of Dapagliflozin and Linagliptin in Tablet Dosage form by QbD Approach

A new simple stability indicating reverse phase liquid chromatography method was developed by employing Quality by Design (QbD) approach for the simultaneous determination of Dapagliflozin and Linagliptin. Within QbD paradigm, the present study aimed to establish the optimization of the RP-HPLC (Reverse phase high performance liquid chromatography) by means of design of experiments and response surface mythology like, Centre composite design (CCD) in order to achieve a good separation and resolution. The developed method is effective to separate Dapagliflozin and Linagliptin with a good chromatographic resolution of 5.272. Chromatographic separation was acquired with column C8 Inertsil column (250 × 4.6 mm, 5 μm) at flow rate 1.0 mL/min with the mobile phase consists of methanol and water (85:15 % v/v). The detection of Dapagliflozin and Linagliptin was carried out at 225 nm. The proposed method was validated according to ICH guidelines. The method was linear in range of 2.5-15 μg/mL and 1.25-7.5 μg/mL of Dapagliflozin and Linagliptin respectively and recovery were in the range of 99% to 100%. The degradation product found in stress patterns were well separated among the drug compounds. The method was validated to be specific, rapid, precise and robust for routine analysis in its pharmaceutical dosage form.