Stability indicating analytical method validation for determination of related substances by rphplc for cyproterone acetate & ethinyl estradiol in cyproterone acetate & ethinyl estradiol tablet

Author: 
Asheesh Singh and Parul Singh

A simple, accurate, rapid and precise cost effective High performance liquid chromatographic (HPLC) method was validated for the determination of related substances in Cyproterone Acetate and Ethinyl Estradiol in tablet formulation. The high performance liquid chromatography resolution was achieved on symmetry C18 250 x 4.6mm, 5µm, column with an gradient elution at a flow rate of 1.0 mL/min using a mobile phase A as buffer and mobile phase B as acetonitrile. The detection was performed by a photo diode array Detector. The method was validated in the concentration range of Limit of quantitation to 150% of working concentration. The intra and inter-day precision and accuracy were within Limit (10 % Relative Standard Deviation). The overall mean recoveries of Cyproterone Acetate and Ethinyl Estradiol impurities were found within limit.

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DOI: 
http://dx.doi.org/10.24327/ijcar.2018.9820.1638
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