A stability indicating UPLC method for determination of temozolomide and its related substances in bulk and finished dosage forms

Abstract

A simple, rapid, sensitive and stability indicating UPLC method has been developed for the quantitative estimation of temozolomide and its impurities in bulk and pharmaceutical dosage. The separation of temozolomide and its impurities was achieved by using Acquity UPLC BEH C18-50 × 2.1 mm, 1.7 µm column maintained at 30 °C with mobile phase consisting of 0.1 % formic acid in water, pH adjusted to 2.8 and acetonitrile in a gradient programme with 12 min run time. The mobile phase flow rate was 0.4 mL/min and the UV detection was carried out at a wavelength of 270 nm. The developed method was able to separate all the process related impurities and degradants of temozolomide with proper separation and also the proposed method was mass compatible. The stability indicating power of the method was verified by performing the forced degradation studies on temozolomide using 0.1 N HCl, 0.1 N NaOH, 3 % hydrogen peroxide, photolytic and thermal degradation studies. The proposed method was validated for specificity, linearity, accuracy, precision, robustness and ruggedness parameters in accordance with ICH guidelines. The validated method can be used for the routine as well as stability analysis in the quality control laboratories.