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Development of HPLC and GC methods for analysis of Zolmitriptan of pharmaceutical purity

Maria Puchalska ,  Joanna Zagrodzka ,  Aleksandra Groman ,  Anna Rosa ,  Katarzyna Badowska-Rosłonek ,  Wioleta Maruszak 

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


Zolmitriptan (4(S)-4-[3-2-dimethyl aminoethyl)-1H-5-indolyl-methyl]-1,3-oxazolan-2-one) belongs to group of medicines known as Serotonin 5-HT1D receptor antagonist. Zolmitriptan is used to treat severe migraine headaches. This cure is available on market as convetional tablets (Zomig), or nasal spray (Zomig nasal spray).

For the determination of pharmaceutical purity of Zolmitriptan, high performance liquid chromatography with spectrophotometric detection is recommended as an analytical technique. The chromatographic separation was achieved on a Waters XTerra RP Column, (250mm, x 4,6 mm, x 5µm) column using linear gradient solutions. As mobile phase – 20 mM ammonium hydrogen orthophosphate and acetonitrile was chosen. In the developed HPLC method, the resolution between Zolmitriptan and its potential impurities, ZL3, ZL4, ZL5, ZL7, werefound to be greater than 3. Obtained product, as pharmaceutical substance, should contain less than 0.5% of total impurities, and no more than 0.10 % of an individual unidentified impurities (acc. ICH). The detection limit (0.5 mg mL-1) for compoud ZL7 obtained using the developed HPLC method with spectrophotometric detection is unsatisfactory. Because of that, for determination of this compound the different method of analysis need to be used. The developed GC method gave an accepted limit of detection for analysis of this potential impurity (75 ppm). The proposed methods, owing to its satisfactory precision and accuracy as well as selectivity, and can be applied for the determination of impurities in pharmaceutical substance.


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Submitted: 2008-03-12 14:03
Revised:   2009-06-07 00:48