Several methods are available for the determination of norethindrone. These methods are either complicated or need validation. The objective of this work was to develop and validate a simple RP-HPLC method for the determination of norethindrone in dissolution media. A Thermo Scientific C18 column (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/min and the wavelength of the detection was 245 nm. Validation of linearity, accuracy and precision, limit of detection, limit of quantification, specificity, and stability (degradation) was carried out according to the ICH guidelines. The developed and validated method was used to study norethindrone release from a nanoparticlute liquid medicated formulation. The results indicated that the method was simple, accurate and precise and met the acceptance criteria. The drug exhibited higher stability in basic media when compared to acidic media. Drug release from a liquid medicated formulation (nanoemulsion) followed zero order kinetics. In conclusion a simple method was developed, validated, and used successfully in evaluating in vitro drug release of a sustained release/controlled release nanoparticulate liquid medicated formulation.
Key words: Norethindrone, RP-HPLC method, dissolution media, Validation, Drug release
|
