Pharmaceutical Analytical Chemistry: Open Access
Open Access
ISSN: 2471-2698
ISSN: 2471-2698
Rashidul Islam
Abeda Inamdar Post Graduate Research Center,
Camp, Pune, Maharashtra
India
Research Article
Development and Validation of RP-HPLC-DAD Stability Indicating Related
Substances Method for the Estimation of Impurities of Norethindrone Tablets
and their Degradation Products
Author(s): Rashidul Islam, Ejazuddin Mohammad Khan, Khursheed Ahmed and Ziyaurrahman AzeezRashidul Islam, Ejazuddin Mohammad Khan, Khursheed Ahmed and Ziyaurrahman Azeez
A novel and efficient stability indicating reverse phase High performance liquid chromatography with diode array detector (RP-HPLC-DAD) related substances analytical method has been developed, optimized and validated for the determination of degradation products and process impurities of Norethindrone in Norethindrone tablets: Noreandrostenedione (Imp-A), Norethindrone enolether (Imp-B), Delta-5(6)Norethindrone (Imp-C), Delta-5(10) Norethindrone (Imp-D). The impurities elution and separation was established by optimized gradient chromatographic parameter using Inertsil ODS-3V (150 mm × 4.6 mm) 5 μ analytical column, water and acetonitrile as mobile phase, with run time 55 minutes, diode array detector (DAD) was set up at 210 nm and 240 nm wavelength for the simultaneous analysis of all impurities. The developed HPLC method was validated as per the International Conference on .. View More»
DOI:
10.4172/2471-2698.1000123