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The development of the analytical methods for studying capsules containing Temozolomide active substance

Marta Majewska 

Instytut Farmaceutyczny (PRI), Rydygiera 8, Warszawa 01-793, Poland


The aim of this work was to develop analytical methods used for studying Temozolomide,    an anti-cancer drug from imidazotetrazine group. Temodal 5 mg, 20 mg capsules manufactured SP Labo N.V. Belgia were used as the reference products.

An RP-HPLC method was developed for the study of assay, dosage uniformity & quantity of the active substance released from the drug form, as well as the purity of the preparation.This method was compared with the spectrophotometric method.

During the purity study, it was observed that the solutions containing Temozolomide were unstable at room temperature. The Temozolomide degradation product was identified as 5(4)-aminoimidazole- 4(5)-carboxyamide (AIC).

The described method succesfully separated the observed impurity from the active substance. The metod was used for the routine analysis of Temozolomide capsules.

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Related papers

Presentation: Poster at VII Multidyscyplinarna Konferencja Nauki o Leku, by Marta Majewska
See On-line Journal of VII Multidyscyplinarna Konferencja Nauki o Leku

Submitted: 2010-03-30 12:22
Revised:   2010-04-05 16:59