Implementing a Quality by Design Approach in Chromatographic Determination of Some Antidiabetic Drugs

This article aims to explain the steps for application of quality by design (QbD) concept to analytical method development and validation, by using an example of simultaneous determination of four antidiabetic drugs (Metformin HCl, Vildagliptin, Sitagliptin phosphate mono hydrate and Pioglitazone HCl) in its pharmaceutical dosage form by RP-HPLC. By using QbD tools, enable earlier understanding and identification of variables