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Application of quality by design approach in RP-HPLC method development for simultaneous estimation of saxagliptin and dapagliflozin in tablet dosage form BJPS
Gundala,Aruna; Prasad,KVSRG; Koganti,Bharathi.
A simple, sensitive, precise, accurate and robust high performance liquid chromatographic method has been developed for simultaneous estimation of saxagliptin (SAXA) and dapagliflozin (DAPA) in pharmaceutical formulation. Design of experiments (DoE) was applied for multivariate optimization of the experimental conditions of RP-HPLC method. Risk assessment was performed to identify the critical method parameters. Three independent factors; mobile phase composition, flow rate and column temperature were used to design mathematical models. Central composite design (CCD) was used to study the response surface methodology and to study in depth the effects of these independent factors. Desirability function was used to simultaneously optimize the retention time...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Saxagliptin/pharmacology Dapagliflozin/pharmacology Quality by Design RP-HPLC/methods Optimization/methods Chromatography High Pressure Liquid/methods Dosage Forms Tablets/administration & Dosage.
Ano: 2019 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502019000100564
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