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Development and Validation of a Reverse-Phase HPLC Method for Analysis of Temozolomide in a Capsule Formulation

K. Vanitha Prakash, B. Mohammed Ishaq and G. Krishnamohan

Temozolomide is an antineoplastic agent with activity against a broad spectrum of murine tumors. A high-performance liquid chromatographic method was developed and validated for the analysis of temozolomide in capsule formulation. In the present work, chromatographic separation of temozolomide was achieved on Waters HPLC with a Zorbax column (4.6 x 150 mm, 3 μ m) using sodium phosphate buffer pH 7: methanol 30:70 v/v at a flow rate of 0.8 mL/min and detection UV wavelength of 287 nm. The injection volume was 20 μ L and the column temperature was maintained at 28°C. The method was validated according to ICH requirements. The valid ation characteristics incl uded accuracy, precision, specificity, linearity, and analytical range. The standard curve was found to have a linear relationship (r 2 = 0.99) over the analytical range of 20-60 μ g/mL. The detection limit was 0.01μg/mL and the quantification limit was 0.03 μg/mL. The recovery /accuracy of the method ranged from 50 to 150%. Data collected in this study were analyzed using JMP statistical so ftware package by one-way analysis of variance (ANOVA). The assay was shown to be specific, accurate, pr ecise, and reliable for use in routine analysis of Temozolomide capsules.