A Stability Indicating RP-HPLC Method Validation for Simultaneous Estimation of Metformin HCl, Dapagliflozin and Saxagliptin in Pharmaceutical Dosage Form
Abstract
Aims: Metformin HCl, Dapagliflozin and Saxagliptin is a new drug combination for the treatment of Diabetes Mellitus which is one of the oldest and lethal diseases of mankind. Aim of the research work was to develop and validate novel, rapid, sensitive, specific, robust stability indicating analytical method for simultaneous estimation of: Metformin HCl, Dapagliflozin and Saxagliptin in pharmaceutical dosage form as fixed dose formulation.
Study Design: Method development and validation was performed as recommended in ICH guideline “Validation of analytical procedures: Test and Methodology Q2 (R1)”.
Methodology: Method develop with chromatographic parameters as C18 column (250mm×4.6 mm, 5mm particle size), HPLC system with PDA detector and mobile phase contained a mixture of Phosphate Buffer pH 3.5 and Acetonitrile (80:20 v/v) + 1 ml triethylamine per 100 ml mobile phase. The flow rate was set to 1 ml/min with responses measured at 265 nm, injection volume was 20 µl, and run time of 15 mins.
Results: The retention time of Metformin HCl, Dapagliflozin and Saxagliptin was 5.8 min, 6.8 mins and 8.4 min respectively with resolution of 3.5 between Metformin HCl and Dapagliflozin and 4.5 between Dapagliflozin and Saxagliptin. Linearity was established in the range of 250-1500 µg/ml for Metformin HCl, 1.25-7.5 µg/ml for Dapagliflozin and Saxagliptin with correlation coefficients more than 0.999. The percentage recoveries were between 98.39-101.66 for Metformin HCl, 99.01-101.77 for…
Read the paper
Related studies
- Metformin as an adjuvant in breast cancer treatment
- Metformin Lysosomal Targeting: A Novel Aspect to Be Investigated for Metformin Repurposing in Neurodegenerative Diseases?
- Aberrant HSF1 signaling activation underlies metformin amelioration of myocardial infarction in mice
- Metformin induces ZFP36 by mTORC1 inhibition in cervical cancer-derived cell lines
- Protein Interaction Network for Identifying Vascular Response of Metformin (Oral Antidiabetic)
- Preventing Long COVID With Metformin
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.