Simultaneous Estimation of Temozolomide and Anastrozole in Capsule Dosage Form by RP-HPLC Method

Abstract

A simple, rapid, accurate, specific and sensitive reverse phase HPLC method has been developed and validated for the simultaneous estimation of temozolomide and anastrozole in bulk drug and pharmaceutical capsule dosage form. The chromatographic separation was performed on the atlantis dC₁₈ column (150 mm × 4.6 mm, 3 μm particle size), using a mobile phase of potassium dihydrogen phosphate pH 3 adjusted with orthophosphoric acid: acetonitrile (65:35 v/v), at a flow rate of 1 mL/min at an ambient temperature of 30 °C with the detection wavelength at 212 nm. The retention times of temozolomide and anastrozole was found to be 2.373 and 6.017 min, respectively. The proposed method has been validated for linearity, range, precision, accuracy and robustness were within the acceptance limit according to ICH Q2B guidelines. Quantification of the components in actual capsule formulations was calculated against the responses of freshly prepared external standard solutions. Linearity for anastrozole and temozolomide was found in range of 0.25-1.00 μg/mL & 25-150 μg/mL and correlation coefficient was found to be 0.999 and 0.9998, % RSD for intermediate precision was found to be 0.123 and 0.258 and for system precision 0.787 and 0.656 %, respectively. The percentage purity of temozolomide and anastrozole was found to be 99.9 and 99.83 %v/v respectively. The method was found to be robust even by change in the mobile phase ± 5 % and in less flow condition.