1Faculty of Pharmaceutical Sciences, Assam Down Town University, Sankar Madhab Path, Gandhi Nagar, Panikhaiti, Guwahati, Assam, India
2Institute of Pharmaceutical Research, GLA University, Mathura, Uttar Pradesh, India
3Faculty of Pharmaceutical Sciences, Assam Down Town University, Sankar Madhab Path, Gandhi Nagar, Panikhaiti, Guwahati, Assam, India
*Corresponding Author E-mail: uttampanigrahy@gmail.com
Online Published on 01 February, 2024.
A simultaneous estimation of Esomeprazole and Ondansetron by HPLC-DAD method with degradation studies was developed.
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.
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.
This method was applicable for routine analysis and stability of Esomeprazole and Ondansetron.
Esomeprazole, Ondansetron, Stress studies, ICH guidelines
