European Journal of Biomedical and Pharmaceutical Sciences

METHOD DEVELOPMENT AND VALIDATION OF BUMETANIDE BY UV SPECTROPHOTOMETRIC METHOD IN BULK AND PHARMACEUTICAL DOSAGE FORM

Chaitanya Boni and Raja Sundararajan*

ABSTRACT

Analytical method development and validation play important role in the discovery, development and manufacture of pharmaceuticals. A simple, rapid and reproducible UV- spectrophotometric method for the quantitative determination of bumetanide in tablet formulation was developed and validated in the present work. Parameters such as linearity, precision and accuracy were studied according to ICH guidelines. The method A was carried out with borate buffer of pH 9 and method B was carried out with phosphate buffer of pH 7. The wavelength 252nm was selected for the estimation of drug using distilled water as a solvent. The drug obeyed Beer-Lambert’s law over the concentration range 5-75μg/ml. The accuracy of the method was assessed by recovery studies and was found between 99.03 – 100.3% for method A and 99.5 – 100.5% for method B. The method was successfully applied for routine analysis of bumetanide drug in formulations.

Keywords: Bumetanide, UV Visible spectrophotometer, Zero-order and First-order derivative and ICH guidelines.