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Stability Indicating RP-HPLC Method for Determination of Tolterodine in Solid Dosage Form


Affiliations
1 Dept. of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal-576 104, Karnataka, India
 

A simple, rapid, and accurate RP-HPLC method was developed for the determination of tolterodine in solid pharmaceutical dosage form. The method showed a linear response for concentration in the range of 1-15μg/ml using acetonitrile:potassium dihydrogen phosphate (50:50,v/v) as the mobile phase with detection at 284 nm and a flow rate of 1ml/min. The method was statistically validated for accuracy, precision, linearity, range, robustness, and stock solution stability. Recovery studies of the dosage form were also carried out and the mean recovery was found to be 98.35±1.01 %. Due to the simplicity, rapidity, and accuracy the method could be used for routine quality control analysis.

Keywords

Tolterodine, HPLC, Degradation Studies.
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  • Stability Indicating RP-HPLC Method for Determination of Tolterodine in Solid Dosage Form

Abstract Views: 176  |  PDF Views: 61

Authors

S. G. Vasantharaju
Dept. of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal-576 104, Karnataka, India
Mishra Akanksha
Dept. of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal-576 104, Karnataka, India
Arumugam Karthik
Dept. of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal-576 104, Karnataka, India
Musmade P. Prashant
Dept. of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal-576 104, Karnataka, India
Udupa Nayanabhirama
Dept. of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal-576 104, Karnataka, India
K. M. Bhat
Dept. of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal-576 104, Karnataka, India

Abstract


A simple, rapid, and accurate RP-HPLC method was developed for the determination of tolterodine in solid pharmaceutical dosage form. The method showed a linear response for concentration in the range of 1-15μg/ml using acetonitrile:potassium dihydrogen phosphate (50:50,v/v) as the mobile phase with detection at 284 nm and a flow rate of 1ml/min. The method was statistically validated for accuracy, precision, linearity, range, robustness, and stock solution stability. Recovery studies of the dosage form were also carried out and the mean recovery was found to be 98.35±1.01 %. Due to the simplicity, rapidity, and accuracy the method could be used for routine quality control analysis.

Keywords


Tolterodine, HPLC, Degradation Studies.