Pramipexole is a new generation dopamine receptor agonist, used as antiparkinson and antidepressant drug. It shows significant lower side effects compared to previous generation drugs (e.g. imipramine).

Pramipexole, namely (S)-(-)-2-amino-6-propylamino-4,5,6,7-tetrahydrobenzotiazole (3) is obtained by direct alkylation of (S)-(-)-2,6-tiamino-4,5,6,7-tetrahydrobenzotiazole (1) with n-propyl tosylate (2) and isolated as monohydrate of dihydrochloride.

The scope of analytical development covered methods for determination of raw materials and intermediates, in process control and certification of final active substances.

Efficient method for routine control of synthetic process was necessary for process optimalization. Reversed phase HPLC technique was applied. Satisfying results were obtained by gradient technique. The same method was used for determination of purity and assay of final product for certification.

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