Abstract

METHOD DEVELOPMENT AND VALIDATION OF NORETHINDRONE BY UV-VISIBLE SPECTROPHOTOMETER IN BULK AND PHARMACEUTICAL DOSAGE FORM

Merugu Manasa*, P. Siva Kumar, N. Sahani, N. Sujatha and P. Sahiti

Abstract

A simple, accurate, precise, and economic method was developed for estimation of Norethindrone acetate in bulk and pharmaceutical dosage form. This is a first method for determination of Norethindrone by UVVisible spectroscopy. Using methanol and water as solvent in 50:50 ratio spectrum was produced and maximum absorbance was found at 256nm. 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 and range was found to be 0.9979, 25 to 100μg/mL. From precision and intermediated precision studies %RSD was found to be 0.22 and 0.88 respectively. LOD and LOQ were found to be 0.9μg/ml and 3μg/ml respectively. Assay was conducted by using Premoult-Nor marketed formulation and percentage purity was found to be 101.91%.

Keywords: Norethindrone acetate, UV-Visible spectroscopy, methanol and water, method development, validation, assay.