Quantification of potential impurities present in testosterone undecanoate active pharmaceutical ingredient by stability indicating HPLC method using UV detector

Amber Bharti, Christine Jeyaseelan.


The study involves the development followed by validation of potential impurities in testosterone undecanoate by high pressure liquid chromatography (HPLC) technique. The chromatographic separation of potential impurities and degradation products were achieved in YMC pack C8 column (150 mm x 4.6 mm, 5 µm) using gradient elution method. For the gradient elution method, mobile phase-A and Mobile phase-B was used. Mobile phase-A was prepared using water and acetonitrile mixture in a ratio of (90:10, v/v) and mobile phase-B was only acetonitrile. Column temperature was kept at 35°C throughout the analysis. Wavelength of 240 nm were selected for the analysis. The current developed method is specific, linear, precise, and accurate. Specificity of the method was confirmed by peak purity analysis using photodiode array detector. Testosterone is the major degradant. The validation study was done as per the current ICH guidelines.


Testosterone undecanoate, Testosterone replacement therapy, Male hypogonadism.

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