ABSTRACT

A new RP-HPLC method was developed for the quantitative determination of tolterodine tartrate in human plasma and validated as per US-FDA guidelines. The drug was spiked in the plasma and extracted with the mobile phase by the precipitation method. The extracted analyte was injected into a Symmetry C18 (4.6 x 150mm, 5 μm, Make: Kromosil), maintained at 25°C and the effluent was monitored at 282 nm. The mobile phase consisted of potassium dihydrogen phosphate [pH 3.0]: acetonitrile [HPLC Grade] (50:50 V/V). The flow rate was maintained at 0.8 mL/min. The calibration curve for tolterodine tartrate was linear from 5.0 to 30.0 µg/mL (r2= 0.999). The inter-day and intra-day precision was found to be within the limits. The Lower Limit of Quantification (LLOQ) for tolterodine tartrate was found to be 0.35µg/mL. The average % recovery for tolterodine was 99.49-100.08% and reproducibility was found to be satisfactory. The proposed method has an adequate sensitivity, reproducibility, and specificity for the determination of tolterodine tartrate in human plasma.