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Development and Validation of Difference Spectrophotometric Method for Zotepine in Bulk and Tablet Dosage Form
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A simple, accurate and specific UV spectrophotometric method was developed and validated for the estimation of ZOT in bulk and tablet dosage form. Analyte showed the absorption maxima at 264nm in 0.1M HCl and at 235nm in 0.1M NaoH. The developed method was validated with respect to linearity, accuracy, precision and specificity. Beer's law was obeyed in the concentration range of 5-35 μg/ml having linear regression equation y=0.0461× + 0.3786 with correlation coefficient of 0.9957. Results of the analysis were validated statistically as per ICH guidelines.
Keywords
Difference Spectrophotometry, Zotepine, Beer’s Law, Validation, ICH Guidelines
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