ABSTRACT

The concept of Quality by design (QbD) has recently gained importance in the area of analytical method development and involves understanding of the critical factors and their interaction effects by a desired set of experiments. So, the present work describes the development of Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) method by AQbD approach using Design of Experiments and subsequent validation for analysis of Imeglimin HCL and Vildagliptin in synthetic mixture. An efficient experimental design based on systematic scouting of all three key components of the RP?HPLC method (Proportion of methanol, flow rate, pH of mobile phase) is presented. The significance and interaction effects of these parameters on the response variables (Retention time, tailing factor and resolution) were evaluated through statistical analysis tools like Analysis of Variance (ANOVA) and plots which revealed the final chromatographic conditions of the method. The developed method was validated and forced degradation studies were also carried out in order to determine the stability-indicating nature of the method. The chromatographic separation was achieved on HIBAR C18, 250*4.6 mm, 5?m column using Acetonitrile: Water (60:40) asmobile phase and detection was carried out using photo diode array detector at 219 nm. The developed method is linear over a range of 50 to 250 ?g/ml for Imeglimin HCL and 2.5 to 12.5 ?g/ml for Vildagliptin, correlation coefficient R2 value as 0.9999 and 0.9963 for Imeglimin HCL and Vildagliptin respectively. The %RSD for precision and accuracy of the method was found to be less than 2%. Forced Degradation studies revealed that the method was found to be stability-indicating. The results showed that the proposed method is suitable for the precise and accurate determination of Imeglimin HCL and Vildagliptin in synthetic mixture. Keywords: Imeglimin HCL, Vildagliptin, RP-HPLC Method, Analytical Quality By Design, Stress testing
Publication date: 01/09/2026

https://www.ijbpas.com/pdf/2026/September/MS_IJBPAS_2026_10136.pdf

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https://doi.org/10.31032/IJBPAS/2026/15.9.10136