HPLC method development and validation for the quantification of related impurities in testosterone cypionate active pharmaceutical ingredient
Bharti, Amber
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.
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.
PHARMACEUTICS
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.
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.
PHARMACEUTICS