TY - JOUR
T1 - Stability-indicating method for the determination of Rivaroxaban and its degradation products using LC-MS and TLC
AU - Arous, Basima
AU - Al-Mardini, Mohammad Amer
AU - Ghazal, Heba
AU - Al-Lahham, Fida
PY - 2018/1/31
Y1 - 2018/1/31
N2 - A validated stability indicating thin layer chromatographic (TLC) and liquid chromatography coupled with mass spectrometry LC/MS methods were developed to analyse Rivaroxaban and its degradation products. Forced degradation studies under stress conditions were carried out in order to establish its stability profile. Stress conditions recommended by the International Conference on Harmonization (ICH) including oxidative, photolytic, thermal, acidic, and basic hydrolysis were applied. Rivaroxaban found susceptible to acid and base hydrolytic stress conditions. Degradation products were identified isolated and characterized using LC-MS and TLC. Three major degradation products were detected, separated and determined and two of them were further characterized by NMR spectroscopy and FT-IR.
AB - A validated stability indicating thin layer chromatographic (TLC) and liquid chromatography coupled with mass spectrometry LC/MS methods were developed to analyse Rivaroxaban and its degradation products. Forced degradation studies under stress conditions were carried out in order to establish its stability profile. Stress conditions recommended by the International Conference on Harmonization (ICH) including oxidative, photolytic, thermal, acidic, and basic hydrolysis were applied. Rivaroxaban found susceptible to acid and base hydrolytic stress conditions. Degradation products were identified isolated and characterized using LC-MS and TLC. Three major degradation products were detected, separated and determined and two of them were further characterized by NMR spectroscopy and FT-IR.
KW - Pharmacy
UR - http://rjptonline.org/AbstractView.aspx?PID=2018-11-1-40
U2 - 10.5958/0974-360X.2018.00040.9
DO - 10.5958/0974-360X.2018.00040.9
M3 - Article
SN - 0974-3618
VL - 11
SP - 212
EP - 220
JO - Research Journal of Pharmacy and Technology
JF - Research Journal of Pharmacy and Technology
IS - 1
ER -