Application of quality by design approach in RP-HPLC method development for simultaneous estimation of saxagliptin and dapagliflozin in tablet dosage form
Título del documento: Application of quality by design approach in RP-HPLC method development for simultaneous estimation of saxagliptin and dapagliflozin in tablet dosage form
Revista: Brazilian Journal of Pharmaceutical Sciences
Base de datos: PERIÓDICA
Número de sistema: 000451008
ISSN: 1984-8250
Autors: 1
2
2
Institucions: 1Krishna Teja Pharmacy College, Department of Quality Assurance, Tirupati, Andhra Pradesh. India
2Sri Padmavati Mahila Visvavidyalayam (Women’s University), Institute of Pharmaceutical Technology, Tirupati, Andhra Pradesh. India
Any:
Volum: 55
País: Brasil
Idioma: Inglés
Tipo de documento: Artículo
Enfoque: Experimental, aplicado
Resumen en inglés 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 and resolution of SAXA and DAPA. The optimized and predicted data from contour diagram consisted of acetonitrile and ortho phosphoric acid (0.1%) in the ratio of 50:50 respectively, at a flow rate of 0.98 ml/min and column temperature 31.4 °C. Using these optimum conditions baseline separation of both drugs with good resolution and run time of less than 6 min were achieved. The optimized assay conditions were validated according to ICH guidelines. Hence, the results clearly showed that Quality by design approach could be successfully applied to optimize RP-HPLC method for simultaneous estimation of SAXA and DAPA
Disciplines Química
Paraules clau: Química farmacéutica,
Química analítica,
Farmacología,
Tabletas,
Saxagliptina,
Dapaglifozina,
Control de calidad,
Optimización,
Cromatografía líquida de alta resolución (HPLC),
Dosificación
Keyword: Medicinal chemistry,
Analytical chemistry,
Pharmacology,
Tablets,
Saxagliptin,
Dapaglifozin,
Quality control,
Optimization,
High performance liquid chromatography (HPLC),
Dosage
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