Method Development and Validation of Film-Coated Vildagliptin Tablets by RP-HPLC Technique

Objective: This study developed and validated a rapid, reliable, and precise reversed-phase HPLC technique for quantitatively detecting Vildagliptin (VLDG) in film-coated tablets. Chromatography was performed on a Waters HPLC system, using a Zorbax SB C18 column as the stationary phase. Materials and methods: Anhydrous sodium 1-heptane sulfonate, trimethylamine, pH was adjusted to 3.0 ± 0.05 (using dilute orthophosphoric acid), with 70:30% v/v methanol as mobile phase. The fluid flow was kept at a constant 1.0 ml/min throughout the analysis. A PDA detector was used to search for radiation at 210 nm. Results: The retention time for VLDG was about 6.5 minutes. The linearity range for VLDG concentrations of 5-25μg/mL was acceptable, with an R2 value of 0.9995. The method was accurate and precise, with an RSD of less than 2%. The percentage of recovery was found to be 99.86-100.16%. Conclusion: The proposed method is highly accurate and sensitive. The process for achieving success using this approach was found to be effective.