DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHOD FOR THE ESTIMATION OF TEMOZOLOMIDE IN CAPSULE DOSAGE FORM
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 UV spectrophotometric method for Temozolomide in bulk and capsule dosage form. The analytical method was validated as per ICH Q2 (R1) guideline and it meets to specific acceptance criteria. The optimum conditions for the analysis of the drug were established. The maximum wavelength (λ max) was found to be 329 nm in 0.1N HCl. Beers law was obeyed in the concentration range of 2-16μg/ml. Calibration curves shows a linear relationship between the absorbance and concentration. The line equation y = 0.055x + 0.033 with r 2 of 0.999 was obtained. The precision of the method was confirmed by intra-day and inter-day analysis. The % RSD value of intra-day and inter-day analysis were found to be 1.500482(standard), 0.679731(sample) and 0.1186 (standard), and 0.2469 (sample) for Temozolomide (10μg/ml) in HCl respectively. The accuracy of the method was performed by recovery studies. The percentage recovery of Temozolomide was found to be in range 98.4 - 99.92%.The proposed method may be suitable for the analysis of Temozolomide in bulk and capsule formulation for quality control purposes.