Reverse-phase, high performance liquid chromatographic method for the determination of tolterodine tartrate in routine quality control samples.

ABSTRACT

A selective, sensitive, and rugged reverse phase-high performance liquid chromatographic method has been developed for the determination of tolterodine tartrate in routine quality control samples. The mobile phase consisted of acetonitrilephosphate buffer (pH 7.0) in 5545 v/v ratio. The mobile phase was also used for the extraction of tolterodine tartrate from its formulations. The chromatography was carried out on a Luna 100A, C-18 (5-micro, 250 x 4.60 mm) column. The software used in the chromatographic analysis was Empower Photodiode Array (PDA) software (Waters, Milford, CT). The UV spectrophotometric determination was done at 210 nm. Retention time was found to be about 7.0 +/- 0.5 min. The standard curve was linear (r2 = 0.9997) over the concentration range of 0.1-0.3 mg/mL. The method was found to be accurate, precise, specific, and rugged. The limit of detection was 0.16 microg/mL and the limit of quantification was 0.489 microg/mL. With a short chromatographic run time, the proposed method can be used for the estimation of large number of quality control samples in a short period.