New Stability-Indicating RP-UFLC Method for Determination of Trospium Chloride in Tablet Dosage Form.

A simple, precise, and accurate isocratic RP-UFLC stability-indicating assay method has been developed to determine trospium chloride in tablet dosage form. Isocratic separation was achieved on an Enable-C18G (250 mm × 4.6 mm i.d., particle size 5 μm) column at room temperature, the mobile phase consisted of acetonitrile:0.01M TBAHS (50:50, v/v) at a flow rate of 1.0 ml/min, the injection volume was 20 μl, and PDA detection was carried out at 215 nm. The drug was subjected to acid and alkali hydrolysis, oxidation, photolysis, and heat as stress conditions. The method was validated for specificity, linearity, precision, accuracy, robustness, and system suitability. The method was linear in the drug concentration range of 10-300 μg/ml with the correlation coefficient being 0.999. The RSD for repeatability and intermediate precision was well below 2%. The mean recoveries were between 100.52-101.68% for trospium chloride.