Validation of Derivative UV Spectrophotometric Methods for Estimation of Temozolomide in Bulk and in Formulatio

Temozolomide is a DNA alkylating agent used to treat specific types of brain cancer. This report describes the validation of simple, rapid, sensitive, and cost-effective zero-order, first-order, and second-order derivative spectrophotometric methods for the estimation of temozolomide in bulk and in its marketed formulation. Preliminary spectrophotometric analysis of the drug was carried out in sodium hydroxide (0.1 N) and hydrochloric acid (0.1 N), and a total of 25 parametric variations were explored. Three method variants employing absorbance (zero-order), peak-to-peak (first-order), and peak-to-zero (second-order) techniques were validated for linearity, accuracy, precision, and robustness. The developed method was validated with respect to parameters including linearity, accuracy, precision, robustness, and solution stability. Excellent linearity was observed in the concentration range of 5.0–40.0 μg/mL, with correlation coefficients of 0.99 or higher for the selected method variants. The assay detection limits ranged from 0.53–1.09 μg/mL, and quantitation limits ranged from 1.61–3.33 μg/mL for the proposed method variants. The proposed methods were used to quantify the drug in its marketed tablet formulation, yielding good recoveries ranging from 97.50–99.05%.

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