TY - JOUR
T1 - Investigation of the temperature stability of premarin intravenous using liquid chromatography-mass spectrometry
AU - Nguyen, Hien P.
AU - Tedmon, Lauren
AU - Li, Li
AU - Wigginton, Jane G.
AU - Maass, David
AU - Gatson, Joshua W.
AU - Simpkins, James W.
AU - Schug, Kevin A.
PY - 2011/7/15
Y1 - 2011/7/15
N2 - Stability of Premarin®Intravenous was investigated in dry and reconstituted forms by monitoring major components in samples for a period of six months, using liquid chromatography-mass spectrometry. The components, largely comprising a series of estrogen and steroid hormone sulfates, were considered to be fairly stable (variation≤10%) for dry samples stored at room temperature and at 38°C (100°F) during the experimental time frame. However, significant variation, especially after 2 months of storage, was observed in reconstituted solutions. This variation was significantly larger for samples stored at elevated vs. room temperature. It was interesting to note that the concentration of equilenin sulfate increased over time, whereas that of other major components were seen to fluctuate and decrease. This phenomenon was partially explained by the conversion of equilin compounds into their corresponding equilenin forms, a phenomenon which was further investigated through a storage study with pure standard solutions and by tandem mass spectrometry.
AB - Stability of Premarin®Intravenous was investigated in dry and reconstituted forms by monitoring major components in samples for a period of six months, using liquid chromatography-mass spectrometry. The components, largely comprising a series of estrogen and steroid hormone sulfates, were considered to be fairly stable (variation≤10%) for dry samples stored at room temperature and at 38°C (100°F) during the experimental time frame. However, significant variation, especially after 2 months of storage, was observed in reconstituted solutions. This variation was significantly larger for samples stored at elevated vs. room temperature. It was interesting to note that the concentration of equilenin sulfate increased over time, whereas that of other major components were seen to fluctuate and decrease. This phenomenon was partially explained by the conversion of equilin compounds into their corresponding equilenin forms, a phenomenon which was further investigated through a storage study with pure standard solutions and by tandem mass spectrometry.
KW - Fragmentation
KW - Premarin
KW - Tandem mass spectrometry
KW - Temperature stability
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U2 - 10.1016/j.jpba.2011.03.003
DO - 10.1016/j.jpba.2011.03.003
M3 - Article
C2 - 21444176
AN - SCOPUS:79956115078
SN - 0731-7085
VL - 55
SP - 1218
EP - 1222
JO - Journal of Pharmaceutical and Biomedical Analysis
JF - Journal of Pharmaceutical and Biomedical Analysis
IS - 5
ER -