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

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.

Sensitive Spectrophotometric Assay of Muscarinic Receptor Antagonist Tolterodine Tartrate in Bulk Drug and Pharmaceutical Formulations

“…Several methods including high performance liquid chromatographic [2][3][4][5][6][7][8][9], electrochemical [10,11] spectrofluorimetric [12], and spectrophotometric [13][14][15][16][17][18][19][20][21][22][23][24][25] methods have been reported for the determination of TOL in pure drug and pharmaceutical formulations. However, these previously reported spectrophotometric methods suffer from one or other disadvantage such as poor sensitivity, depending on critical experimental variables; few methods require a rigid pH control and tedious and time-consuming liquid-liquid extraction step and use of expensive reagent or large amounts of organic solvents.…”

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“…It is used in the management of urinary frequency, urgency and incontinence in detrusor instability 2 . Literature survey shows that several spectrophotometric [3][4][5][6][7][8][9] and chromatographic [10][11][12][13][14][15][16][17][18] methods for determination of tolterodine in pure form, pharmaceutical preparations and/or biological fluids have been reported.…”