Spectrophotometric Determination of Tenatoprazole in Bulk Drug and Pharmaceutical Dosage Form
Kumaraswamy Gandla, J.M. Rajendrakumar, J.V.L.N. Sheshagirirao, U. Ashok Kumar, M. Arunadevi
Abstract
Kumaraswamy Gandla, J.M. Rajendrakumar, J.V.L.N. Sheshagirirao, U. Ashok Kumar, M. Arunadevi
Abstract
A simple efficient, precise and accurate spectroscopic method has been developed and validated for quantitative estimation of Tenatoprazole in bulk drug and pharmaceutical dosage form. Tenatoprazole is dissolved in 0.1M Hydrochloric and the resulting solution was then scanned in the UV range (200-400nm) in a 10 mm quartz cell in a double beam UV spectrophotometer. The λmax of Tenatoprazole was found to be 314nm.The method obey's Beers law in the concentration range from 3–18 μg/ml. The correlation coefficient was found to be 0.9997 (r2= 0.9997). The LOD and LOQ were found to be 0.9882 and 1.9482μg/ml respectively. The result of estimation of marketed tablet formulation (Allegro) was found to be 99.47% with their % RSD 0.4362.The accuracy of the method was determined by recovery studies. The percentage recovery was found to be 99.83%. The method was validated statistically as per ICH guidelines. The method showed good reproducibility and recovery with % RSD less than 2. So, the proposed method was found to be simple, specific, precise, accuracy, linear, and rugged. Hence it can be applied for routine analysis of Tenatoprazole in bulk drug and the Pharmaceutical formulations.
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A simple efficient, precise and accurate spectroscopic method has been developed and validated for quantitative estimation of Tenatoprazole in bulk drug and pharmaceutical dosage form. Tenatoprazole is dissolved in 0.1M Hydrochloric and the resulting solution was then scanned in the UV range (200-400nm) in a 10 mm quartz cell in a double beam UV spectrophotometer. The λmax of Tenatoprazole was found to be 314nm.The method obey's Beers law in the concentration range from 3–18 μg/ml. The correlation coefficient was found to be 0.9997 (r2= 0.9997). The LOD and LOQ were found to be 0.9882 and 1.9482μg/ml respectively. The result of estimation of marketed tablet formulation (Allegro) was found to be 99.47% with their % RSD 0.4362.The accuracy of the method was determined by recovery studies. The percentage recovery was found to be 99.83%. The method was validated statistically as per ICH guidelines. The method showed good reproducibility and recovery with % RSD less than 2. So, the proposed method was found to be simple, specific, precise, accuracy, linear, and rugged. Hence it can be applied for routine analysis of Tenatoprazole in bulk drug and the Pharmaceutical formulations.
Key concepts: Dosage form, Reproducibility, Chromatography, Pharmaceutical formulation, Correlation coefficient, Mathematics, Hydrochloric acid, Beer–Lambert law