2024
DOI: 10.1002/jssc.202300605
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Analytical quality by design approach for the development of high‐performance liquid chromatography method for simultaneous analysis of metformin and sitagliptin in the presence of major degradation products

Rajesh Pawar,
Pothuraju Naresh,
Bhadrayya Kalva
et al.

Abstract: An analytical quality by design‐based high‐performance liquid chromatography method for determining metformin (MET) and sitagliptin (SIT) in stress‐degraded samples was developed and validated. The analytical target profile and risk assessment‐driven critical method variables, for example, pH, % aqueous, and buffer concentration, were studied for their effect on method responses of retention time and resolution using a central composite design. The correlation regression coefficient was more than 0.8, and vari… Show more

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