alexa Abstract | Physico-chemical characterization, UV spectrophotometric method development and validation studies of Esomeprazole Magnesium Trihydrate

Journal of Chemical and Pharmaceutical Research
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Original Articles Open Access

Abstract

Esomeprazole magnesium trihydrate (EMT) is a proton pump inhibitor used against peptic ulcer disease to suppress excess acid secretion in the stomach. Physico chemical characterization studies showed that EMT has showed a melting point of 177.330 C. The solubility of drug esomeprazole followed the order methanol>ethanol> acetone> buufer pH 9.0 > distilled water. The analytical method developed for the estimation of esomeprazole magnesium trihydrate in bulk fluids showed maximum absorbance λmax of 203.5 nm in methanol between 200 nm and 400 nm. Linearity studies indicated that estimation of esomeprazole magnesium trihydrate between 2.00 μg /ml to 10.00 μg /ml was found to be linear with regression equation of y = 0.1546*X - 0.00414; ( r2 = 0.999). The method developed was validated for inter and intra day variation, limit of quantitation studies. The SD values of Inter day and Intra day variation studies indicated that the variation is minimum. Limit of Quantitation of esomeprazole was found to be of 1.00 μg /ml. The above analytical parameters indicated that the developed UV Spectrophotometric method of esomeprazole was simple, accurate and reproducible.

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Author(s): Putta Rajesh Kumar Somashekar Shyale Mallikarjuna Gouda M and S M Shanta Kumar

Keywords

Esomeprazole magnesium trihydrate (EMT), UV Spectrophotometric Method.

 
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