David m bliesner validating chromatographic methods


14-Oct-2019 13:37

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The method was found to be suitable for the stability, release, in process and Quality control analysis.The developed method is stability indicating, specific, selective, simple, precise, cost effective, linear and robust.Norethindrone tablets works by suppressing ovulation, thickening cervical mucus to prevent sperm penetration, and altering the lining of the uterus [1,2].Impurities will be quantified as known Impurities: Noreandrostenedione (Imp-A), Norethindrone enoloether (Imp-B), Delta-5(6)Norethindrone (Imp-C), Delta-5(10)Norethindrone (Imp-D).

david m bliesner validating chromatographic methods-25

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More than 24 hours solution stability of impurities, reference solution and test solution is not yet reported [2- 4]. Reference standard and impurity standard of Norethindrone and Norethindrone tablets 0.35 mg were obtained as gift sample from Bayer, India.

Limit of detection (LOD) and limit of quantification (LOQ) were also obtained for all impurities.

Norethindrone samples and placebo were subjected to stress conditions of hydrolysis (acid and base), oxidative, and thermal stress degradation.

Received Date: July 05, 2017; Accepted Date: July 10, 2017; Published Date: July 13, 2017 Citation: Rashidul I, Khan EM, Ahmed K, Azeez Z (2017) Development and Validation of RP-HPLC-DAD Stability Indicating Related Substances Method for the Estimation of Impurities of Norethindrone Tablets and their Degradation Products. doi: 10.4172/2471-2698.1000123 Copyright: © 2017 Rashidul I, et al.

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This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.Norethindrone; HPLC; Degradation products; Related substances; Method validation RP-HPLC-DAD: Reverse Phase-High Performance Liquid Chromatography-Diod Array Detector; UV: Ultra Violet; PDA: Photo Diode Array; HCL: Hydrochloric acid; Na OH: Sodium hyderoxide; H: Hyderogen Peroxide; Acc: Accuracy; nm: Nanometer; RSD: Relative Standard Deviation; SD: Standard Deviation; μ: Micrometer; LOQ: Limit of Quantitation; LOD: Limit of Detection; Imp-A: Noreandrostenedione; Imp-B: Norethindrone enolether; Imp-C: Delta-5(6)Norethindrone; Imp-D: Delta-5(10)Norethindrone and RRT: Relative Retention Time.



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