Development and Full Validation of a Stability-indicating HPLC Method for the Determination of the Anticancer Drug Temozolomide in Pharmaceutical Form

[摘要] Objectives: In the present study, an accurate, precise and simple method has been developed for the determination of TMZ in its pharmaceutical form by using HPLC. Materials and Methods: An HPLC method with a DAD was validated according to ICH guidelines. A C18 column (150x4.6 mm. i.d., 5 µm particle size) and an aqueous acetate buffer (0.02 M)-acetonitrile (90:10, v/v) (pH 4.5) as a mobile phase were used. Results: The linear range and LOD value were 5-100 µg/mL and 0.02 µg/mL, respectively. The accuracy of the method was determined using a recovery test and found as 98.8-100.3%. In addition, forced degradation studies of the drug were also performed in bulk drug samples to demonstrate the specificity and stability-indicating. Degradation studies under acidic, basic, oxidative, and thermal degradation conditions were applied. Conclusion: The proposed method could be applied successfully for the determination and identification of the degradation of the drug.

[关键词] Temozolomide;HPLC;validation;determination;degradation