ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF FEXOFENADINE IN BULK AND PHARMACEUTICAL DOSAGE FORM BY UV SPECTROSCOPY

Dr. Chennupati V. Suresh*, Amathul Noor Nimra, M. Pavitra, G. Sridhar, Santhosh Illendula and Dr. K. N. Venkateswara Rao

ABSTRACT

A new simple, accurate, rapid, precise, reproducible and cost-effective spectrophotometric method for the quantitative estimation of Fexofenadine. The developed UV spectrophotometric method for the quantitative estimation of Fexofenadine is based on measurement of absorption at maximum wavelength 248.5 nm using, Methanol & Ammonium acetate buffer as a solvent. The stock solution of Fexofenadine was prepared and subsequent suitable dilution was prepared in distilled water to obtained standard curve. The standard solution of Fexofenadine shows absorption maxima at 248.5 nm. The drug obeyed beer lambert’s law in the concentration range of 5 - 25 μg/ml with regression 1 at 248.5 nm. The overall % recovery was found to be 99.17% 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 0.943888 & 0.649186 respectively which is <2% hence proved that method is precise. The results of analysis have been validated as per International Conference on Harmonization (ICH) guidelines. The developed method can be adopted in routine analysis of Fexofenadine in bulk and tablet dosage form.

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