Development of a New Related Substance by HPLC Method for Vildagliptin for Quantification of Purity

Abstract

Using a simple, quick, precise, and cost-effective approach, a new method for measurement of Vildagliptin in Active Pharma Ingredient (API) besides its relative substance was developed and validated. This method is simple, rapid, exact and cost-effective. With isocratic elution of buffer acetonitrile and methanol in the proportions of (87:10:3 v/v/v), the chromatographic separation was done on an ODS-4 C18 column (3 m 250 4.6 mm) using a 4.6-millimeter ODS-4 C18 column. Using a photodiode array (PDA) detector, we measured the flow rate of one milliliter per minute (ml/min), the column temperature of fifty degrees Celsius, and the detection wavelength of two hundred and ten nanometers (nm). Vildagliptin has a theoretical plate of 8000 and a tailing factor of 1.38, making it one of the most potent drugs available. The approach was validated in compliance with the International Conference on Harmonization (ICH) and the Food and Drug Administration (FDA) requirements. Precision, accuracy, and resilience were all high on the list of desirable characteristics.