A Stability Indicating RP-HPLC Method Validation for Simultaneous Estimation of Metformin HCl, Dapagliflozin and Saxagliptin in Pharmaceutical Dosage Form

Aims: Metformin HCl, Dapagliflozin and Saxagliptin is a new drug combination for the treatment of Diabetes Mellitus which one oldest lethal diseases mankind. Aim research work was to develop validate novel, rapid, sensitive, specific, robust stability indicating analytical method simultaneous estimation of: in pharmaceutical dosage form as fixed dose formulation.
 Study Design: Method development validation performed recommended ICH guideline “Validation procedures: Test Methodology Q2 (R1)”.
 Methodology: with chromatographic parameters C18 column (250mm×4.6 mm, 5mm particle size), HPLC system PDA detector mobile phase contained mixture Phosphate Buffer pH 3.5 Acetonitrile (80:20 v/v) + 1 ml triethylamine per 100 phase. The flow rate set ml/min responses measured at 265 nm, injection volume 20 µl, run time 15 mins.
 Results: retention 5.8 min, 6.8 mins 8.4 min respectively resolution between HCl 4.5 Saxagliptin. Linearity established range 250-1500 µg/ml 1.25-7.5 correlation coefficients more than 0.999. percentage recoveries were 98.39-101.66 99.01-101.77 98.88-101.87 Validation evaluated according International Conference on Harmonization (ICH) R1 guidelines. forced degradation studies by using NaOH, H2O2, thermal UV Radiation. developed successfully applied quantification hyphenated instrumental analysis.
 Conclusion: Significance that it can be utilize routine or unknown sample analysis assay various Pharmaceutical Industry.