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 the
main reasons quality is lost in pharmaceuticals is the absence of appropriate and valid analytical
techniques. This paper aims to describe the development and verification of a Quality by
Design (QbD) RP-HPLC method to determine Vildagliptin in bulk and tablet dosage forms
using Central Composite Design. The research methodology investigated how the factors of
the chromatograph impact the separation performance (Y) of TICs using a Central Composite
Design (CCD). The selected factors included the concentrations of acetonitrile and flow rate.
The chromatography for this experiment was performed on an Agilent Zorbax C18 column
with a mobile phase of phosphate buffer and acetonitrile (40:60 v/v) and a flow rate of 1.0
mL/min, measuring response at 218 nm. The method developed in accordance with the
principles outlined in the ICH Q2(R2) Note for guidance. Outcome: The optimized method has
approximately 2.7 minutes as retention time and an r2 100.83 percent, which is incredibly
precise. After an accurate study, the total reproducibility of percent was determined to be less
than two percent. The results of the ANOVA demonstrated there is statistically significant
difference between the models developed and established the significance of the
chromatographic variables on retention time via CCD value of 1.0000, indicating an exact
linear relationship. The average percent recovery has been determined to beThe efficient
development, validation, and use of the QbD- RP-HPLC method for determining vildagliptin
is a result of the creation of the type of method developed through the use of CCD to optimise
efficiency and reduce the number of experimental trials. The method used is expected to add
further knowledge about the quality of the vildagliptin, whether in the form of the raw product
or one of the forms on the market today.