TY  - GEN
AU  - Bharti, Amber 
AU  -  Kumbhare, Ravindra Motiram
TI  - HPLC method development and validation for the quantification of related impurities in testosterone cypionate active pharmaceutical ingredient
PY  - 2022///
CY  - Karnataka
PB  - Association of Pharmaceutical Teachers of India (APTI)
KW  - PHARMACEUTICS
N2  - 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
UR  - https://www.ijper.org/sites/default/files/IndJPhaEdRes-56-1-240.pdf
ER  -