Abstract

METHOD DEVELOPMENT AND VALIDATION OF ALOGLIPTIN BY UV SPECTROSCOPIC METHOD

Dr. CH. V. Suresh*, E. Poojitha, K. Umesh, A. Vamshi, E. Hemanth, Dr. K.N.V. Rao, Santhosh Illendula

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Abstract

A new simple, accurate, rapid, precise, reproducible and cost-effective spectrophotometric method for the quantitative estimation of Alogliptin. The developed UV spectrophotometric method for the quantitative estimation of Alogliptin is based on measurement of absorption at maximum wavelength 277 nm using Methanol & Water as a solvent. The stock solution of Alogliptin was prepared and subsequent suitable dilution was prepared in distilled water to obtained standard curve. The standard solution of Alogliptin shows absorption maxima at 277 nm. The drug obeyed beer lambert’s law in the concentration range of 5 - 25 μg/ml with regression 1 at 277 nm. The overall % recovery was found to be 99.4% which reflects that the method was free from the interference of the impurities and other excipients used in the marketed dosage 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 0.5454 & 0.8564 respectively which is

Keywords: Alogliptin, UV Visible Spectrophotometry, Method development, Validation, ICH guidelines, Accuracy &s Precision.