Abstract

A Novel Validated High Performance liquid chromatographic stability indicating assay method for the chemical analytical quantification of Norethindrone Tablets and their degradation study

Author(s): Rashid Azeez*, Masood Ahmed Siddiqui and Ziyaurrahman Azeez

Norethindrone is a synthetic chemical analogue of naturally occurring steroid whose structure is chemically based on a steroid nucleus-a hydrogenated cyclopentanoperhydrophenanthrene ring having 17 carbon atoms. This is new drug and vital in medicine. Tablet dosage form is new pharmaceutical formulation and used as oral contraceptive. They are low dose and have less label claim. The development and validation of assay method by RP-HPLC-DAD is challenging and not yet reported. The objective of this research was to develop and validate a precise, efficient, specific, accurate and stability indicating RP-HPLC-DAD assay method for the quantification of Norethindrone in Norethindrone tablets and their forced degradation studies. This HPLC method developed have a reverse phase Inertsil ODS-3V, 150 x 4.6mm, 5μ column, a mixture of amine buffer pH 2.5 and acetonitrile as mobile phase in isocratic mode with UV detection wavelength 240 nm. The method was validated and found to be precise, robust, accurate, linear in the range of 17 to 52 μg /mL (r2 = 0.9984) and specific for Norethindrone and degradation products ensuring suitability of the method for quantitative determination of Norethindrone. Solution stability evaluation indicated no evidence of degradation product, forced degradation study of Norethindrone shown that peak was pure and there was no co eluting peaks when samples were assayed against reference standard. Method was useful for routine analysis and quality check of Norethindrone formulations.

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