ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF TEMOZOLOMIDE IN PHOSPHATE BUFFER USING UV SPECTROPHOTOMETER
Temozolomide is an oral chemotherapy drug. 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 330 nm in Phosphate Buffer pH 2.0. Beers law was obeyed in the concentration range of 4-18μg/ml. Calibration curves shows a linear relationship between the absorbance and concentration. The line equation y = 0.053x + 0.006 with r2 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 0.487401(standard), 0.447029(sample) and 0.2070 (standard), 0.5253 (sample) for Temozolomide (10μg/ml) in Phosphate Buffer pH 2.0 respectively. The accuracy of the method was performed by recovery studies. The percentage recovery of Temozolomide was found to be in range 98.47 – 100.4%.The proposed method may be suitable for the analysis of Temozolomide in bulk and capsule formulation for quality control purposes