Preformulation, Characterization, Estimation and Method Validation Studies of Esomeprazole Magnesium Trihydrate by UV –Visible Spectrophotometry

Author(s)

Narwal, S.N., Saini, V.P.

Author's Affiliation

Abstract

The present paper comprises Preformulation characterization and Method Validation of UV-visible Spectrophotometric method for the estimation of Esomeprazole Magnesium trihydrate. It is a very simple, accurate, sensitive, economical and reproducible UV-spectrophotometric method. Esomeprazole Magnesium trihydrate (EMT) is a proton pump inhibitors which is used against peptic ulcer disease to prevent excess amount of acid secretion in the stomach .The standard and sample solutions of Esomeprazole Magnesium trihydrate were prepared in simulated salivary fluid pH 6.8 and in 0.1N NaOH solution. Physico- chemical characterization studies showed that EMT has showed a melting point of 174-176°C. The maximum solubility of Esomeprazole Mg trihydrate was found in Dichloromethane. The Partition Coefficient of drug was found to be 613.75 .The analytical method developed for the estimation of Esomeprazole Magnesium trihydrate shows maximum absorbance λmax of 301nm in simulated salivary fluid pH 6.8 and 305 nm in 0.1N NaOH. The linear regression analysis data for the calibration plots showed a good linear relationship over the concentration range of 2-20μg/ml for Esomeprazole Magnesium trihydrate. The developed method was validated according to ICH guidelines. The interday and intraday precision of EMT was found to be within limits (less than 2). The developed method has precise sensitivity and specificity for the determination of Esomeprazole Magnesium trihydrate and is found to be cost effective. Accuracy (80%, 100%, 120%) and reproducibility were found to be satisfactory. Statistical analysis data showed that the method is repeatable, sensitive and selective for the estimation of Esomeprazole Magnesium trihydrate. The above analytical parameters indicated that the developed UV Spectrophotometric method was simple, accurate and reproducible.

Keywords

Esomeprazole, UV-Visible spectrophotometer, Estimation, Simulated salivary fluid (6.8 pH), Validation

Cite This Article

Narwal, S.N., Saini, V.P. (2016). Preformulation, Characterization, Estimation and Method Validation Studies of Esomeprazole Magnesium Trihydrate by UV –Visible Spectrophotometry, International Journal for Pharmaceutical Research Scholars (IJPRS), 5(1), 151-161.