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UV Derivative Spectrophotometric Methods for Validation of Esomeprazole Magnesium Tri-Hydrate in Bulk and Pharmaceutical Dosage Form


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1 Central Research Laboratory, D.G. Ruparel College, Matunga, Mumbai 400016, India
     

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The objective of the study was to develop simple, accurate, precise and rapid UV first and second order derivative spectrophotometric methods with subsequent validation by using ICH guidelines for the determination of Esomeprazole magnesium tri-hydrate in pharmaceutical dosage form. The proposed first and second order derivative methods involve the measurement of absorbance of drug at 293 nm and 281 nm for the estimation of Esomeprazole magnesium tri-hydrate respectively. The linearity of the proposed methods were found in the concentration range of 4-40 μg /ml (r2= 0.9999) for first order and second order derivative methods and the percentage mean recovery was found to be 99.59 % to 100.69 % respectively. The methods were also statistically validated for its linearity, accuracy and precision. Both intra and inter day variation showed less percentage (%) RSD values indicating high grade of precision of these methods.

Keywords

UV Derivative Spectrophotometric Estimation, Esomeprazole Magnesium Tri-Hydrate, Validation.
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  • UV Derivative Spectrophotometric Methods for Validation of Esomeprazole Magnesium Tri-Hydrate in Bulk and Pharmaceutical Dosage Form

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Authors

Rajan V. Rele
Central Research Laboratory, D.G. Ruparel College, Matunga, Mumbai 400016, India

Abstract


The objective of the study was to develop simple, accurate, precise and rapid UV first and second order derivative spectrophotometric methods with subsequent validation by using ICH guidelines for the determination of Esomeprazole magnesium tri-hydrate in pharmaceutical dosage form. The proposed first and second order derivative methods involve the measurement of absorbance of drug at 293 nm and 281 nm for the estimation of Esomeprazole magnesium tri-hydrate respectively. The linearity of the proposed methods were found in the concentration range of 4-40 μg /ml (r2= 0.9999) for first order and second order derivative methods and the percentage mean recovery was found to be 99.59 % to 100.69 % respectively. The methods were also statistically validated for its linearity, accuracy and precision. Both intra and inter day variation showed less percentage (%) RSD values indicating high grade of precision of these methods.

Keywords


UV Derivative Spectrophotometric Estimation, Esomeprazole Magnesium Tri-Hydrate, Validation.

References