TO DEVELOP AND VALIDATE SUITABLE ANALYTICAL METHODS FOR THE QUANTIFICATION OF TOLTERODINE TARTRATE USING UV-VISIBLE SPECTROPHOTOMETRY AND REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (RP-HPLC)

The aim of this research was to develop and validate a stability-indicating Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method for the estimation of Tolterodine Tartrate (TRT) in bulk and tablet dosage forms. Chromatographic separation was achieved using a C18 column (250 mm × 4.6 mm, 5 μm particle size) with a mobile phase consisting of Propylene glycol: Water (pH 4.5) (pH adjusted with Orthophosphoric acid): Methanol in the ratio of 50:40:10. The flow rate was maintained at 1.0 mL/min, and detection was carried out at 282 nm using a UV detector. The retention time of drug was found to be 5.793 for Tolterodine Tartrate (TRT). The method was validated according to ICH guidelines for linearity, accuracy, precision, specificity, limit of detection (LOD), limit of quantification (LOQ), and robustness. Linearity was observed in the concentration range of 10-50 μg/mL for TRT, with correlation coefficients (r²) of 0.9993. The method demonstrated good accuracy, with recovery rates found in the range of 99.80% to 100.86 % for TRT. Precision, both intra-day and inter-day, showed relative standard deviation (RSD) values of less than 2%. The stability study involves the good results in all stability conditions. The marketed formulation of Tolterodine Tartrate was analysis using UV and RP-HPLC the percent assay by both methods was found to be 98.23% and 98.68% respectively. The developed RP-HPLC method is reliable, efficient, and suitable for the estimation of Tolterodine Tartrate in in bulk and tablet dosage forms. It can be successfully applied for routine quality control and stability testing of these agents.