Quantitative Determination of Tartaric Acid in Tolterodine Tartrate by Ion Chromatography Using Conductivity Detection

The present paper deals with the development and validation of analytical method based on a single column high performance Ion chromatography with cation suppressed conductivity detection, developed for quantitation of tartaric acid. The diluent used for the preparation of sample solution was water and injected into a standard chromatographic system connected with 250mm length, 4.0 mm ID and 5.0 μm particle size Metrosep A supp 5 Ion exchange column and suppressed conductivity detector. The developed analytical method was highly precise and accurate compared to titration methods and HPLC-UV detection methods to analyze the counter-ion tartaric acid in Tolterodine tartrate drug substance. Calibration curves were linear with correlation co-efficient of > 0.999 for tartaric acid. The % RSD of area response of tartaric acid in standard injections was below 1.0, which demonstrates the system precision. The % RSD of results in samples is below 1.0, which demonstrates the method precision of the test procedure. The accuracy of the method is also studied and observed between 99% and 101%. The developed method was validated according to ICH guidelines for the quantitative determination of tartaric acid in Tolterodine tartrate taken for the study.