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The determination of chromatografic purity of Pramipexole Dihydrohloride Monohydrate

Agata E. Kamieńska-Duda ,  Bożenna A. Kosmacińska ,  Agnieszka Ciesielska 

Pharmaceutical Research Institute (IF), Rydygiera 8, Warszawa 01-793, Poland


The aim of this study was to develop the chromatographic method (HPLC) for determination of pramipexole and its two impurities: S(-)-4,5,6,7-tetrahydrobenzothiazol-2,6-diamine (DA) and dihydrochloride monohydrate (S)(-)-4,5,6,7-tetrahydro-N6,N6dipropylbenzothiazole-

2,6-diamine (Imp. A). The chemical structures of tested substances are presented in Figure 1.


Several methods have been tested and finally the method using C18 column and the mobile phase containing 1-octanosufonic acid salt was chosen. The method has been validated and the following parameters were tested: specificity and selectivity, linearity, detection and quantitation limits, precision, intermediate precision, accuracy and robustness. The acceptance criteria were fulfiled.

The method has been applied in testing the stability of pramiexole under stress conditions. The tests included: the effect of oxidation on API and stability in the acidic and alkaline conditions.

It was found that the influence of 1 M HCl on PXS is minimal, the influence of 3 %H 2O2 is noticeable and the influence of 1M NaOH is significant. The additional peaks of unknown substances appeared in the chromatograms of the tested solutions.


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Presentation: Poster at VI Multidyscyplinarna Konferencja Nauki o Leku, by Bożenna A. Kosmacińska
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Submitted: 2008-04-09 09:31
Revised:   2009-06-07 00:48