Chromatographic study of sitagliptin and ertugliflozin under quality-by-design paradigm
Braz. J. Pharm. Sci. (Online)
;
59: e21328, 2023. tab, graf
Article
Dans Anglais
| LILACS
| ID: biblio-1439548
ABSTRACT
Abstract The present study entails the systematic development and validation of a stability-indicating RP-HPLC method for the analysis of sitagliptin and ertugliflozin in a fixed-dose combination. Analytical quality by design (AQbD) concepts were used to define critical method variables, employing Pareto risk assessment and a Placket-Burman screening design, preceded by a Box-Behnken design with response surface analysis to optimise critical method parameters such as % acetonitrile (X1), buffer pH (X2) and column oven temperature (X3). Multiple response optimisation (Derringer's desirability) of variables was accomplished by studying critical analytical attributes, such as resolution, retention time and theoretical plates. The title analytes were separated effectively on a PRONTOSIL C18 column at 37 °C using a mobile phase of acetonitrileacetate buffer, pH 4.4 (3664 percent v/v), pumped at a flow rate of 1 mL/min, and UV detection at 225 nm. Linearity was observed over a concentration range of 25-150 µg/mL and 3.75-22.5 µg/mL at retention times of 2.82 and 3.92 min for sitagliptin and ertugliflozin, respectively. The method obeyed all validation parameters of the ICH Q2(R1) guidelines. The proposed robust method allows the study of the selected drugs in pharmaceutical dosage forms as well as in drug stability studies under various stress conditions.
Texte intégral:
Disponible
Indice:
LILAS (Amériques)
Sujet Principal:
Dessin
/
Phosphate de sitagliptine
Type d'étude:
Facteurs de risque
langue:
Anglais
Texte intégral:
Braz. J. Pharm. Sci. (Online)
Thème du journal:
Farmacologia
/
Teraputica
/
Toxicologia
Année:
2023
Type:
Article
Pays d'affiliation:
Inde
Institution/Pays d'affiliation:
Osmania University/IN
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