Analytical quality by design based on design space in reversed-phase-high performance liquid chromatography analysis for simultaneous estimation of metformin, linagliptin and empagliflozin

Royal Society Open Science

Amira H. Kamal¹  Sherin F. Hammad¹  Mohamed M. Salim²  Aya A. Marie²  Mahmoud M. Elkhoudary² 

[1] Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Tanta University, Tanta 31527, Egypt;Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Horus University-Egypt, New Damietta 34517, Egypt;

关键词: analytical quality by design;    ATP;    metformin;    linagliptin;    empagliflozin;    human plasma;   

DOI  :  10.1098/rsos.220215

来源: DOAJ

【 摘 要 】

Employing the Quality by Design paradigm through this work helped conclude the method operable design region for optimizing the high performance liquid chromatography (HPLC) assay using Design of Experiments and response surface methodology to obtain a good resolution and determination of all analysed compounds and to achieve a suitable analysis time. A deep understanding of the quality target product profile, analytical target profile and risk assessment for parameters that affect the method performance led to developing an accurate, precise and cost-effective method. Quality risk management principles were applied for determining the critical method parameters affecting the simultaneous determination of metformin hydrochloride (MET), linagliptin (LIN) and empagliflozin (EMP) by reversed-phase HPLC . The ternary mixture was successfully resolved in 5 min with a linearity range of (0.1–600) µg ml−1 for MET and (0.05–50) µg ml−1 for LIN and EMP. The newly developed method was validated according to the International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use guidelines. Good agreement was observed with the assay results of the reported UPLC one. To evaluate the greenness of the proposed method, an analytical Eco-Scale method was used.

【 授权许可】

Unknown