A new method for assaying propantheline and its degradation product, xanthene-9- carboxylic acid using high performance liquid chromatography

A rapid, specific, and precise high-performance liquid chromatographic method is described for the simultaneous analysis of propantheline bromide and its hydrolysis product, xanthene-9-carboxylic acid. Reversed-phase chromatography was conducted using a mobile phase of 40:60, acetonitrile-0.05 M phosphate buffer (pH 2.5) delivered at 2 ml/min. Detection was at 254 nm. Methantheline bromide (internal standard), propantheline bromide, and xanthene-9-carboxylic acid gave retention times of 4.1, 5.4, and 8.3 min, respectively. Within-day, between-day, and total precision (CV) for assay of 15 mg/10 ml propantheline bromide are 1.2, 1.1, and 1.6%, respectively (n = 20). Similar precision was obtained for xanthene-9-carboxylic acid. The limit of detection was 2 ng. The assay is useful for routine quality assurance of propantheline in dosage forms and for stability and kinetic studies