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).

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2. Application of HPLC for studying purity, content and release profile of temozolomide capsules