ABSTRACT
Several methods are available for the determination of norethindrone. These methods are either complicated or needvalidation. The objective of this work was to develop and validate a simple reversed phase-high performance liquidchromatographic method for the determination of norethindrone in dissolution media. A Thermo Scientific C18column (250 mm × 4.6 mm ID, 5 µm pore size) was used. A mobile phase consisting of deionized water: acetonitrile(50:50, v/v) and 5 ml/l acetic acid was used. The flow rate was 1.3 ml/minute and the wavelength of the detectionwas 245 nm. Validation of linearity, accuracy and precision, limit of detection, limit of quantification, specificity, andstability (degradation) was carried out according to the International Conference on Harmonization guidelines. Thedeveloped and validated method was used to study norethindrone release from a nanoparticulate liquid medicatedformulation (LMF). The results indicated that the method was simple, accurate and precise, and met the acceptancecriteria. The drug exhibited higher stability in basic media when compared to acidic media. Drug release from a LMF(nanoemulsion) followed zero order kinetics. In conclusion, a simple method was developed, validated, and usedsuccessfully in evaluating in vitro drug release from a sustained release/controlled release nanoparticulate LMF.