Identification of Unknown Impurities in Cefprozil Suspension by LC-HR-MS/MS / 中国药房
China Pharmacy
;
(12): 1217-1222, 2020.
Artículo
en Chino
| WPRIM
| ID: wpr-821610
ABSTRACT
OBJECTIVE:To de termine unknown impurities in Cefprozil suspension ,and to identify its structure. METHODS : LC-HR-MS/MS method was used to detect and identify unknown impurities in Cefprozil suspension. The determination was performed on Thermo HyPURITY TM C18 with mobile phase consisted of acetonitrile- 0.013% formic acid solution (gradient elution ) at the flow rate of 1.0 mL/min. The detection wavelength was set at 230 nm,and column temperature was 40 ℃. The sample size was 20 μL. ESI+ full scanning was carried out with electrospray ion source scanning range was mass-charge ratio (m/z)100-1 500 with spray voltage of 3.8 kV,metal capillary temperature of 320 ℃,sheath gas pressure of 60 Arb,auxiliary gas pressure of 10 Arb,spray temperature of 280 ℃. RESULTS :Under this condition ,the detection limit of impurity K was 0.202 μg/mL. RSDs of precision and reproducibility tests were both lower than 4%. Three unknown impurities were found around impurity K ,which were isomers of each other. The retention time of ions were 17.83-19.31 min,and the secondary parent ion were all m/z 436.150 0[M+ H]+,which may be the product of ring opening and dehydration of cefpropene. CONCLUSIONS :Three unknown impurities near impurity K in Cefprozil suspension were detected by this method.
Texto completo:
Disponible
Índice:
WPRIM (Pacífico Occidental)
Tipo de estudio:
Estudio diagnóstico
Idioma:
Chino
Revista:
China Pharmacy
Año:
2020
Tipo del documento:
Artículo
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