Abstract

METHOD DEVELOPMENT AND VALIDATION OF NEVIRAPINE BY UV-VISIBLE SPECTROPHOTOMETER IN BULK AND PHARMAEUTICAL DOSAGE FORM

Merugu Manasa*, A. Ramya, Ameena Shireen, Ankit Kumar Varma, A. P. Nirmala

ABSTRACT

A specific, accurate, precise and reproducible method was developed for estimation of nevirapine by UV-Visible spectroscopy, using methanol and water as solvent in 50: 50 ratio spectrum was produced and maximum absorbance was found at 249nm. Then the method was optimized and validated for various parameters. By conducting accuracy percentage recovery was found to be 100.2%. From linearity studies correlation coefficient R2 an range was found to be 0.9979, 25 to 150μg/mL. From precision and intermediate precision studies %RSD was found to be0.22 and 0.88 respectively. LOD and LOQ were found to be 0.9μg/ml and 3μg/ml Respectively. Assay was conducted by using marketed formulation of nevirapine and the percentage purity was found to be 101.91%. Hence this method was suitable for estimation of pharmaceutical substance and product.

Keywords: Nevirapine, UV-Visible spectroscopy, methanol and water, method development, validation, assay, pharmaceutical substance, pharmaceutical product.