Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry and Computational Chemistry

Abstract

Ultra performance liquid chromatography (UPLC) method development and validation fordetermination of impuritiesof Norethindrone tablets using advanced T3 Bonding process

Author(s): Bhaskara P. V. Mantena, Sumathi V. Rao, D. Suryakala, K. Ramakrishna and Srikanth Reddy R

An advanced Ultra performance liquid chromatography (UPLC) method has been developed and validated for determination of process and degradation impurities in Norethindrone tablets. The chromatographic separation was achieved by using Acquity UPLC HSS T3 (100 mm × 2.1 mm), 1.8m column, with shorter run time 11 minutes. Method validation parameters such as specificity, linearity, precision, accuracy, determination of LOD and LOQ and robustness were evaluated as per ICH guidelines. The validated UPLC method was successfully applied to the quantitative determination of impurities of Norethindrone in tablet dosage form. The method was found to be suitable for the quality control and to assure therapeutic efficacy. The described method is simple, rapid, linear, precise and robust.


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