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Volume: 9, Issue: 2, February, 2019
DOI: 10.7324/JAPS.2019.90211



Research Article

RP-HPLC method for determination of norethindrone in dissolution media and application to study release from a controlled release nanoparticulate liquid medicated formulation

Suhair S. Al-Nimry, Bashar M. Altaani, Razan H. Haddad

  Author Affiliations


Abstract

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 reversed phase-high performance liquid chromatographic 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/minute 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 International Conference on Harmonization guidelines. The developed and validated method was used to study norethindrone release from a nanoparticulate liquid medicated formulation (LMF). 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 LMF (nanoemulsion) followed zero order kinetics. In conclusion, a simple method was developed, validated, and used successfully in evaluating in vitro drug release from a sustained release/controlled release nanoparticulate LMF.

Keywords:

Norethindrone, RP-HPLC method, dissolution media, validation, drug release.



Citation: Al-Nimry SS, Altaani BM, Haddad RH. RP-HPLC method for determination of norethindrone in dissolution media and application to study release from a controlled release nanoparticulate liquid medicated formulation. J Appl Pharm Sci, 2019; 9(02):079–086.


Copyright: The Author(s). This is an open access article distributed under the Creative Commons Attribution Non-Commercial License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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