The aim of the study was to develop analytical methods for the determination of temozolomide, an anti-cancer drug from the imidazotetrazine group [1]. Temodal 5 mg, 20 mg and 100 mg capsules manufactured by SP Labo N. V. (Belgium) and the drug obtained in the Pharmaceutical Research Institute (Poland) were used.

Fig. 1. Temozolomide

The analytical method for the purity study was characterized by good HPLC parameters:

• High separation
• Short time of analysis
• Favorable peak’s symmetry
• A lot of theoretical plates

No unidentified impurities were detected both in the reference product and the capsules manufactured in the Pharmaceutical Research Institute. The only identified impurity AIC (5-amino-imidazole-4-carboxamide) met tight acceptance criteria. The developed methods are in accordance with the Pharmacopea’s [2] requirements regarding HPLC methods.

Fig. 2. 5-amino-imidazole-4-carboxamide (AIC)

1. Hong Kim, Paul Likhari, Donald Parker, Paul Statkevich, Aliceann Marco, Chin-Chung Lin, Amin A. Nomeir “High-performance liquid chromatographic analysis and stability of anti-tumor agent temozolomide in human plasma”  J. Pharm. Biomed. Anal. 24 (2001) 461-468
2. Ph.Eu. VIII

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