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Development and Validation of Difference Spectrophotometric Method for Zotepine in Bulk and Tablet Dosage Form


Affiliations
1 Department of Pharmaceutical Chemistry, Sinhgad Institute of Pharmaceutical Sciences, Lonavala, Pune – 410 401, Maharashtra, India
     

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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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  • Development and Validation of Difference Spectrophotometric Method for Zotepine in Bulk and Tablet Dosage Form

Abstract Views: 1008  |  PDF Views: 1

Authors

Mrudula Kulkarni
Department of Pharmaceutical Chemistry, Sinhgad Institute of Pharmaceutical Sciences, Lonavala, Pune – 410 401, Maharashtra, India
Pratibha Dange
Department of Pharmaceutical Chemistry, Sinhgad Institute of Pharmaceutical Sciences, Lonavala, Pune – 410 401, Maharashtra, India
Sanjay Walode
Department of Pharmaceutical Chemistry, Sinhgad Institute of Pharmaceutical Sciences, Lonavala, Pune – 410 401, Maharashtra, India

Abstract


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

References