Article · Volume 56, Issue 1 · pp. 240–246
HPLC Method Development and Validation for the Quantification of Related Impurities in Testosterone Cypionate Active Pharmaceutical Ingredient
Amber Bharti1,2, Ravindra Motiram Kumbhare3, Christine Jeyaseelan1
- 1Department of Chemistry, Amity Institute of Applied Sciences, Amity University, Noida, Uttar Pradesh, INDIA.
- 2Ipca Laborotaries Ltd., GIDC Estate, Nandesari, Vadodara, Gujarat, INDIA.
- 3Fluoro-Agrochemicals Department, CSIR-Indian Institute of Chemical Technology, Tarnaka, Hyderabad, Telangana, INDIA.
Abstract
Aim: The purpose of this research study, is to develop and validate a reverse phase HPLC test method for detecting relevant impurities in Testosterone cypionate (TCY).Materials and Methods: The chromatographic system for separation of related impurities were achieved in Zorbax XDB-C8 (15 cm x 4.6 mm), 5 micron HPLC column utilising gradient elution technique. Water was selected as solvent-A and Acetonitrile was preferred as solvent-B for mobile phase. The method is gradient technique. Column heater was kept constant at 35°C; the rate of flow was 1.2 mL per min; volume of injection was 20 μL and 240 nm was set for detector wavelength.Results: The % recovery was in the range of 95.6% to 108.7% for all impurities. The result of correlation coefficient were higher than 0.98. Testosterone is the major degradants obtained from forced degradation study.Conclusion: The created method can be utilise in quality control testing on a regular basis for the analysis of Testosterone cypionate.
Keywords: Testosterone cypionate; Testosterone replacement therapy; Male; hypogonadism; HPLC; Impurity profiling
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