QBD driven analytical method development and validation of metformin and dapagliflozin by using reverse phase-high performance liquid chromatography
نویسندگان
چکیده
A simple, sensitive, precise, accurate, and robust, high-performance liquid chromatographic method has been developed to simultaneously estimate Metformin (MET) Dapagliflozin (DAPA) in pharmaceutical formulation. Design of experiments (DoE) was applied for multivariate optimization the experimental conditions RP-HPLC method. risk assessment performed identify critical parameters. The mobile phase composition, flow rate, column temperature were used design mathematical models. Box Behnken (BBD) study response surface methodology effects these independent factors. desirability function optimize retention time resolution MET DAPA. optimized predicted data from contour diagram consisted acetonitrile ortho phosphoric acid (0.1%) ratio 50:50, respectively, at a rate 1.0 ml/min 29°C. Using optimum conditions, baseline separation both drugs with good run less than 5 min achieved. assay validated according ICH guidelines. Hence, results clearly showed that Quality by approach could be successfully simultaneous estimation
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ژورنال
عنوان ژورنال: International Journal of Health Sciences (IJHS)
سال: 2022
ISSN: ['2550-6978', '2550-696X']
DOI: https://doi.org/10.53730/ijhs.v6ns4.10505