AQbD guided optimization and validation of RP-HPLC method for Vildagliptin

Vildagliptin is an anti-diabetic drug used primarily for type 2 diabetes mellitus. One of themain reasons quality is lost in pharmaceuticals is the absence of appropriate and valid analyticaltechniques. This paper aims to describe the development and verification of a Quality byDesign (QbD) RP-HPLC method to determine Vildagliptin in bulk and tablet dosage formsusing Central Composite Design. The research methodology investigated how the factors ofthe chromatograph impact the separation performance (Y) of TICs using a Central CompositeDesign (CCD). The selected factors included the concentrations of acetonitrile and flow rate.The chromatography for this experiment was performed on an Agilent Zorbax C18 columnwith a mobile phase of phosphate buffer and acetonitrile (40:60 v/v) and a flow rate of 1.0mL/min, measuring response at 218 nm. The method developed in accordance with theprinciples outlined in the ICH Q2(R2) Note for guidance. Outcome: The optimized method hasapproximately 2.7 minutes as retention time and an r2 100.83 percent, which is incrediblyprecise. After an accurate study, the total reproducibility of percent was determined to be lessthan two percent. The results of the ANOVA demonstrated there is statistically significantdifference between the models developed and established the significance of thechromatographic variables on retention time via CCD value of 1.0000, indicating an exactlinear relationship. The average percent recovery has been determined to beThe efficientdevelopment, validation, and use of the QbD- RP-HPLC method for determining vildagliptinis a result of the creation of the type of method developed through the use of CCD to optimiseefficiency and reduce the number of experimental trials. The method used is expected to addfurther knowledge about the quality of the vildagliptin, whether in the form of the raw productor one of the forms on the market today.