ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF TEMOZOLOMIDE IN PHOSPHATE BUFFER PH 2.0 AS A SOLVENT BY UV SPECTROSCOPY

Abstract

Temozolomide is an antineoplastic agent with activity against a broad spectrum of murine tumors. This compound is currently marketed for the treatment of patients with glioblastoma multiforme and anaplastic astrocytoma, which are serious and aggressive types of brain cancers. The present research work discusses the development and validation of a UV spectrophotometric method for temozolomide. Simple, accurate, precise and cost efficient spectrophotometric method has been developed for the estimation of temozolomide in bulk and capsule dosage form. The optimum conditions for the analysis of the drug were established. The maximum wavelength (λ max) was found to be 330 nm in Phosphate Buffer pH 2.0. The percentage recovery of temozolomide was found to be in range 98.47 – 100.4 %. Beers law was obeyed in the concentration range of 4-18 μg/ml. Calibration curves shows a linear relationship between the absorbance and concentration. The line equation y = 0.053x + 0.006 with r 2 of 0.999 was obtained. Validation was performed as ICH guidelines for Linearity, accuracy, precision, LOD and LOQ. The proposed method may be suitable for the analysis of temozolomide in bulk and capsule formulation for quality control purposes.