摘要
目的:建立了高效液相色谱法测定磷酸特地唑胺原料药对映异构体的方法。方法:采用CHIRALPAK■AGP(150 mm×4.0 mm,5μm)色谱柱,以磷酸二氢铵缓冲液为流动相A,以甲醇为流动相B,梯度洗脱,检测波长300 nm。结果:在该色谱条件下,特地唑胺和对映异构体之间的分离度均能达到1.5以上;对映异构体的检测限为相当于主成分浓度的0.02%;对映异构体在0.5~20μg/mL范围内线性良好,(r≥0.990,n=6);对映异构体的准确度在95.0%~100.0%之间,(RSD≤5.0)。结论:本方法可用于特地唑胺对映异构体的检测。
An HPLC method was established for the determination of enantiomer of tedizolid phosphate drug substance. Method:A CHIRALPAK■ AGP(150 mm×4.0 mm,5μm)was used. Ammonium dihydrogen phosphate buffer was used as mobile phase A and methanol as mobile phase B, Gradient elution with detection wavelength of 300 nm. Results:Under this chromatographic condition, the degree of separation between tedizolid phosphate and enantiomers can reach 1.5 or more;the detection limit ofenantiomers is equivalent to 0.02% of the main component concentration;The enantiomers were well linear in the range of 0.5~20 μg/mL( r≥0. 990,n=6). The accuracy of enantiomerswas between 95.0% and 100.0%(RSD≤5.0).Conclusion:The established method is suitablefor the determination of enantiomer of tedizolid phosphate.
作者
曾羽
刘运栋
Zeng Yu;Liu Yundong(College of Pharmaceutical Sciences,Soochow University,Jiangsu Suzhou 215000)
出处
《化工时刊》
CAS
2019年第10期9-11,共3页
Chemical Industry Times
