ACTA Pharmaceutica Sciencia 2021 , Vol 59 , Num 3
A Stability Indicating UV-HPLC Method for the Determination of Potential Impurities in Nandrolone Phenylpropionate Active pharmaceutical ingredient
Amber BHARTI 1 Christine JEYASEELAN 1
1 Department of chemistry, Amity Institute of Applied Sciences, Amity University, Uttar Pradesh, Noida 201303, India
DOI : 10.23893/1307-2080.APS.05924 A reverse phase stability indicating HPLC method has been developed for the identification and quantification of potential impurities in Nandrolone phenylpropionate active pharmaceutical ingredient. The chromatographic separation of potential impurities was achieved in Inertsil ODS-3Vcolumn (250 mm x 4.6 mm, 5 µm) using gradient elution method. Mobile phase-A was prepared using 0.1% orthophosphoric acid in water and methanol mixture in a ratio of (90:10, v/v) and mobile phase-B was only acetonitrile. The developed method was validated as per the ICH guidelines for specificity, linearity, precision and accuracy. Specificity of the method was confirmed by peak purity analysis using photodiode array (PDA) detector. The value of correlation coefficient was greater than 0.999 for Nandrolone phenylpropionate and its six impurities. Accuracy of the method was established between 93.3% to 109.0% for all impurities. Nandrolone was found to be the major degradation impurity. The proposed method is suitable for routine as well as stability studies. Keywords : Nandrolone phenylpropionate, nandrolone, anabolic, steroid

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