ABSTRACT

As per requisition of current regulatory requirements, simple, rapid and sensitive method by 33 factorial QbD approach was established and validated for Empagliflozin (EPZ) and Metformin Hydrochloride (MTF) by RP-HPLC. Equipped with Reverse Phase (Agilent) C18 column (4.6mm x 100mm; 2.5?m), a 20?l injection loop and UV730D Absorbance detector at 231nm wave length and running chemstation 10.1 software and drugs along with degradants were separated via Methanol: (0.1% OPA) Water (70:30) of pH 3.2 as mobile phase setting flow rate 0.7 ml/min at ambient temperature. The developed method was found linear over the concentration range of 2-10 ?g/ml for EPZ and 20-100 ?g/ml for MTF while detection limit and quantitation limit were found to be 0.629 ?g/ml, 1.23 ?g/ml and 1.03 ?g/ml, 3.28 ?g/ml respectively for EPZ and MTF. There are no interfering peaks underperformed degradation conditions. Therefore, a sensitive, robust, accurate and stability indicating method was developed with high degree of practical utility. Keywords: Empagliflozin, Metformin Hydrochloride, QbD, RP-HPLC, Stability Study, Analytical method development
Publication date: 01/09/2023

https://ijbpas.com/pdf/2023/September/MS_IJBPAS_2023_7399.pdf

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https://doi.org/10.31032/IJBPAS/2023/12.9.7399