Abstract

DEVELOPMENT AND VALIDATION OF UV-VISIBLE SPECTROPHOTOMETRICAL METHOD FOR THE ESTIMATION OF ASPIRIN-DEXLANSOPRAZOLE COMBINATION

*Amala Sara George, Kunnath Kamarunissa, Athira J. S., Dr. Prasanth S. S.

ABSTRACT

Rapid, simple and specific analytical methods using UV spectrophotometry was established for the estimation of drugs that are used as proton pump inhibitors. The developed methods were validated according to ICH guidelines for linearity, precision, accuracy, limit of detection, limit of quantification and robustness. The proton pump inhibitors are used as an effective cure for acid-peptic disorders by blocking the proton pumps (H+_K+ ATPase) on the walls of the esophagus, stomach and duodenum. The significance of these proposed
methods have made them more convenient and can be utilized effectively for routine analytical purpose. The pure samples of Dexlansoprazole and Aspirin showed best solubility in methanol and hence methanol was used as both the solvent and diluent. Methods were developed by using UV Visible spectrophotometry. Simultaneous equation method or Vierodt’s method is used here. In this method, if the sample containing two absorbing drugs, one drug absorbs at the 𝛌max of the other. Hence, both the drugs can be estimated. The proposed UV spectrophotometric methods showed linearity within the concentration range 4-20 𝜇g/ml for Dexlansoprazole and 26- 130𝜇g/mL for Aspirin. The maximum absorption was shown at a wavelength 282nm for Dexlansoprazole and 274nm for Aspirin. The accuracy study was carried out at 3 levels of percent recovery (80%, 100% and 120%) and precision by replicate analysis. The percentage recoveries were shown to be 99.65% and 97.43% for Dexlansoprazole and Aspirin, respectively. Validation of this method was performed in accordance with ICH guidelines.

Keywords: Vierodt’s method, Dexlansoprazole, Aspirin, absorption maxima, percentage recovery.