METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF TOLTERODINE IN TABLET DOSAGE FORM BY RP-HPLC

Abstract

A simple, precise, and robust reverse phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the quantitative estimation of Tolterodine in tablet dosage forms. Chromatographic separation was achieved on a YMC Triart C18 column (250 × 4.6 mm, 5.0 µm) using a mobile phase of 10 mM ammonium bicarbonate in water and acetonitrile (70:30, v/v) at a flow rate of 0.7 mL/min with detection at 280 nm. The method was validated as per ICH Q2(R1) guidelines, evaluating specificity, linearity, accuracy, precision, robustness, system suitability, limit of detection (LOD), and limit of quantification (LOQ). Calibration was linear across the 2–12 µg/mL range with a regression coefficient (R²) of 0.999. Recovery ranged from 98–102%, and intra/inter-day precision studies showed %RSD values below 2%. The method demonstrated consistent results under minor variations in flow rate and column temperature, confirming robustness. The validated method is rapid, sensitive, accurate, and suitable for routine quality control and stability analysis of Tolterodine in pharmaceutical dosage forms Keywords: Tolteridone, RP- HPC, Validation, ICH Guidelines