The proposed RP- HPLC method using QbD approach provides simple accurate, and reproducible quality analysis for determination of Sitagliptin phosphate. 32 factorial design were used. study interaction of 2 factors were selected as dependent variables i.e mobile phase composition and flow rate and independent variables i.e retention time and tailing factor were evaluated through the runs in design. The chromatographic method with C-18 column, PDA detector, 70:30 (%v/v) methanol : water as mobile phase with flow rate of 1ml/min at wavelength of 267nm. The method is validated in compliance with ICH guideline and validation parameters was studied and performed. All the results were within the specification. The Quality by Design approach has been successfully used to develop RP-HPLC method for Sitagliptin phosphate. All key aspect of QbD were tried to be implemented in study.
Hamid et al. (Wed,) studied this question.