A Novel Analytical approach for Simultaneous Estimation of Esomeprazole and Ondansetron by HPLC-DAD Method with Degradation Studies

Abstract

Objective: A simultaneous estimation of Esomeprazole and Ondansetron by HPLC-DAD method with degradation studies was developed. Method: It was carried out using Kromasil (150mm×4.6mm, 5µm particle size) column with mobile phase consists 0.01M KH2PO4 Phosphate buffer (1mL of Triethylamine added and pH was adjusted to 3.5 with Orthophosphoric acid): Acetonitrile (35:65, %v/v) with flow rate 1mL/min at 265nm. Esomeprazole and Ondansetron were eluted at 2.350 and 2.831mins respectively. Results and Discussion: Validation was performed as per ICH guidelines, which shows linearity 25-150μg/mL of Esomeprazole and 10-60μg/mL of Ondansetron with R2 was 0.999. Accuracy was obtained to be 99.75-100.21% for Esomeprazole and 99.39-100.3% for Ondansetron respectively and precision which shows %RSD less than 2%. Stress studies were carried out which shows that both Esomeprazole and Ondansetron is moderately degraded in acid, base, peroxide and thermal degradation and less degraded in photolytic degradation. Conclusion: This method was applicable for routine analysis and stability of Esomeprazole and Ondansetron.