摘要
目的建立高效液相色谱法测定醋酸来法莫林的有关物质。方法采用C_(18)色谱柱(25 cm×4.6 mm,5μm),流动相A:60 mmol/L磷酸二氢钾溶液(磷酸调pH至2.5)-乙腈(80:20,V/V),流动相B:60 mmol/L磷酸二氢钾溶液(磷酸调pH至2.5)-乙腈(50:50,V/V),梯度洗脱;流速1 mL/min;检测波长210 nm;柱温30℃;进样体积20μL。结果醋酸来法莫林与各有关物质分离良好;醋酸来法莫林在0.50~75.33μg/mL的浓度范围内,浓度与峰面积呈良好的线性关系,相关系数为1.000,醋酸来法莫林的检测限为0.20μg/mL。结论该方法专属、可靠,可用于醋酸来法莫林有关物质的测定。
Objective To establish a high performance liquid chromatography method for the determination of related substances in lefamulin acetate.Methods A C_(18)column(25 cm×4.6 mm,5μm)was used with mobile phase A:60 mmol/L potassium dihydrogen phosphate solution(pH adjusted to 2.5 with phosphoric acid)-acetonitrile(80:20,V/V),mobile phase B:60 mmol/L potassium dihydrogen phosphate solution(pH adjusted to 2.5 with phosphoric acid)-acetonitrile(50:50,V/V),gradient elution,flow rate at 1 mL/min,detection wavelength at 210 nm,column temperature at 30℃,and injection volume of 20μL.Results Lefamulin acetate was well separated from the related substances.Lefamulin acetate was within the concentration range of 0.50~75.33μg/m L,and the concentration and peak area showed a good linear relationship.The correlation coefficient was 1.000.The limit of detection is 0.20μg/m L.Conclusion This method is exclusive and reliable,and can be used for the determination of related substances in lefamulin acetate.
作者
何美翠
张春然
黄清东
王宇驰
王瑛瑛
于瑶
张静霞
李知仪
赵欢
唐克慧
He Mei-cui;Zhang Chun-ran;Huang Qing-dong;Wang Yu-chi;Wang Ying-ying;Yu Yao;Zhang Jing-xia;Li Zhi-yi;Zhao Huan;Tang Ke-hui(Antibiotics Research and Re-evaluation Key Laboratory of Sichuan Province,Sichuan Industrial Institute of Antibiotics,School of Pharmacy,Chengdu University,Chengdu 610106;Sichuan Baite Wenli Technology Co.,Ltd,Chengdu 611731)
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
2022年第9期926-932,共7页
Chinese Journal of Antibiotics
作者简介
何美翠,女,生于1994年,在读硕士研究生,研究方向为药物质量研究,E-mail:1405630207@qq.com;通讯作者:张春然,E-mail:379550816@qq.com
