#189 Analytical method development and validation for the estimation of Tolterodine in bulk and dosage form

Abstract

A new simple, accurate, and economical reverse-phase high-performance liquid chromatographic method was developed for the estimation of Tolterodine in bulk and tablet dosage form. The separation was eluted on Agilent TC C18 column (250 mm x 4.6 mm; 5 μm) using a mobile phase mixture of 0.1% orthophosphoric acid and methanol in a ratio of 50:50 v/v at a flow rate of 1.2 mL/min. The detection was made at 220 nm. The retention time was 3.7 min. The calibration curve was linear over the 5-30 μg/mL concentration range. The percentage recovery obtained was 100.36%. The proposed method was validated as per the ICH guidelines parameters like linearity, specificity, precision, accuracy, robustness, and ruggedness. The method was accurate, precise, specific, and rapidly found to be suitable for the quantitative analysis of the drug and dosage form.