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Development and Validation of UV– Spectrophotometric Method of Tolterodine in bulk and Pharmaceutical Dosage Form


Affiliations
1 Department of Pharmaceutical Analysis, Malla Reddy College of Pharmacy, Secunderabad, India
2 Sir C.R. Reddy College of Pharmaceutical Sciences, Eluru, India
     

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A simple, precise and accurate UV Spectrophotometric method has been developed for estimation of Tolterodine in bulk and tablet dosage form. In this method Tolterodine shows max at 280nm using 0.1N NaOH as a solvent. The proposed method was validated as per ICH Q2 (R1) guidelines for precision, linearity, accuracy and recovery. The responses were linear in the range of 10-80μg/ml. The regression equation of the calibration graph and correlation coefficient were found to be y=0.006×- 0.003 and 0.999 respectively. The recovery of the drug from the sample was ranged between 99.62% and 100.76%. The % RSD values for both intraday and interday precision were less than 1%. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.715μg/ml and 2.167μg/ml respectively by simple UV spectroscopy.

Keywords

Tolterodine, UV-Spectroscopy, Validation, NaOH, ICH Guidelines
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  • Development and Validation of UV– Spectrophotometric Method of Tolterodine in bulk and Pharmaceutical Dosage Form

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Authors

B. Siddartha
Department of Pharmaceutical Analysis, Malla Reddy College of Pharmacy, Secunderabad, India
I. Sudheer Babu
Sir C.R. Reddy College of Pharmaceutical Sciences, Eluru, India
A. Krupalini
Department of Pharmaceutical Analysis, Malla Reddy College of Pharmacy, Secunderabad, India
V. Prathyusha
Department of Pharmaceutical Analysis, Malla Reddy College of Pharmacy, Secunderabad, India

Abstract


A simple, precise and accurate UV Spectrophotometric method has been developed for estimation of Tolterodine in bulk and tablet dosage form. In this method Tolterodine shows max at 280nm using 0.1N NaOH as a solvent. The proposed method was validated as per ICH Q2 (R1) guidelines for precision, linearity, accuracy and recovery. The responses were linear in the range of 10-80μg/ml. The regression equation of the calibration graph and correlation coefficient were found to be y=0.006×- 0.003 and 0.999 respectively. The recovery of the drug from the sample was ranged between 99.62% and 100.76%. The % RSD values for both intraday and interday precision were less than 1%. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.715μg/ml and 2.167μg/ml respectively by simple UV spectroscopy.

Keywords


Tolterodine, UV-Spectroscopy, Validation, NaOH, ICH Guidelines

References