Physical preparation or complex structure of API may cause many analytical problems. Therfore elaboration of suitable analytical methods for both routine manufacturing processes and investigation of novel synthetic routes is very important.

Analytical method used for this purpose must ensure fast and efficient determination of the presence of starting materials, product, impurities and side products. Nowadays, the common and widely applied method which meets these requirements is high performance liquid chromatography, especially in reverse phase mode (RP-HPLC). This technique was used for optimization of synthesis and determination of purity of tolterodine tartrate – an active substance administered in urinary incontinence therapy.

Synthesis of the active substance – tolterodine - was conducted in two different ways: first one consisted of seven synthetic steps, and second one of eight steps. The method described in this poster is useful for both synthetic pathways and suitable for determination of product purity, as well as separation and identification of impurities and side products.

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