Abstract

A NEW ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ESTIMATION OF DECITABINE BY UV SPECTROSCOPIC METHOD

Santhosh Illendula*, Budida Manasa, Chinthapally Ganesh, Mohammad Bushra,

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Abstract

A new simple, accurate, rapid, precise and reproducible spectrophotometric method for the quantitative estimation Decitabine in bulk form. The developed visible spectrophotometric method for the quantitative estimation of Decitabine is based on measurement of absorption at maximum wavelength 254 nm using with Methanol: water (30:70) as a solvent. The stock solution of Decitabine was prepared, and subsequent suitable dilution was prepared in diluent to obtained standard curve. The standard solution of Decitabine shows absorption maxima at 254 nm. The drug obeyed beer lambert’s law in the concentration range of 5 - 25 μg/ml with regression 0.9991 at 254 nm. The overall % recovery was found to be 99.22% which reflects that the method was free from the interference of the impurities and other excipients used in the bulk form. The low value of % RSD was indicative of accuracy and reproducibility of the method. The % RSD for inter-day and intra-day precision was found to be 0.81103 and 0.9856, respectively which is

Keywords: Decitabine, UV Visible Spectrophotometry, Method development, Validation, ICH guidelines, Accuracy, Precision.