Bharti, Amber  <br/><br/>
HPLC method development and validation for the quantification of related impurities in testosterone cypionate active pharmaceutical ingredient 

 - Vol.56(1), Jan-Mar 
 - Karnataka  Association of Pharmaceutical Teachers of India (APTI)  2022 
 - 240-246p. 
<br/><br/> Aim: The purpose of this research study, is to develop and validate a reverse phase HPLC<br/>test method for detecting relevant impurities in Testosterone cypionate (TCY). Materials<br/>and Methods: The chromatographic system for separation of related impurities were<br/>achieved in Zorbax XDB-C8 (15 cm x 4.6 mm), 5 micron HPLC column utilising gradient<br/>elution technique. Water was selected as solvent-A and Acetonitrile was preferred as<br/>solvent-B for mobile phase. The method is gradient technique. Column heater was kept<br/>constant at 35°C; the rate of flow was 1.2 mL per min; volume of injection was 20 μL<br/>and 240 nm was set for detector wavelength. Results: The % recovery was in the range<br/>of 95.6% to 108.7% for all impurities. The result of correlation coefficient were higher<br/>than 0.98. Testosterone is the major degradants obtained from forced degradation study.<br/>Conclusion: The created method can be utilise in quality control testing on a regular basis<br/>for the analysis of Testosterone cypionate. 
<br/><br/><label>Subjects--Topical Terms: </label><br/>PHARMACEUTICS