摘要
目的建立高效液相色谱法测定氯霉素硼酸酊两组分的含量及有关物质。方法采用Universil XB-C18(150 mm×2. 1 mm,3μm)色谱柱,流动相为体积分数为1%的冰乙酸水溶液(A)-乙腈(B),梯度洗脱,流速为0. 2 mL·min-1;检测波长为270 nm;柱温为35℃。结果 4-羟基基间苯二甲酸、氯霉素二醇物、对羟基苯甲醛、氯霉素与水杨酸均能良好分离;4-羟基间苯二甲酸、氯霉素二醇物、对羟基苯甲醛、氯霉素、水杨酸分别在0. 1375~1. 375 mg·L-1(r=0. 999 8)、0. 937 5~9. 375 mg·L-1(r=0. 999 5)、0. 125 0~1. 250 mg·L-1(r=0. 999 6)、95. 20~952 mg·L-1(r=0. 999 2)、123. 2~1232 mg·L-1(r=0. 999 8)内线性关系良好,4-羟基间苯二甲酸、氯霉素二醇物、对羟基苯甲醛的回收率分别为97. 78%、99. 21%、99. 82%,RSD为2. 69%、1. 30%、2. 0%(n=9)。结论该方法适用于该制剂中氯霉素、水杨酸的含量测定及有关物质检查。
Objective This article is to establish a UPLC method for the determination of two components of chloramphenicol borate bismuth and its impurity content.Methods The separation was developed on a Universil XB-C18 column(150 mm×2.1 mm,3μm)by gradient elution with acetonitrile-water(containing1%(φ)aqueous acetic acid)as the mobile phase,flowrate was 0.2 mL·min-1,detection wavelength at270 nm and column temperature was 35℃.Results The calibration curve was linear within the range of0.137 5-1.375 mg·L-1(r=0.999 8)for 4-hydroxyisophthalicacid,0.937 5-9.375 mg·L-1(r=0.999 5)for chloramphenicol glycols,0.125 0-1.250 mg·L-1(r=0.999 6)for p-hydroxybenzaldehyde,95.20-952 mg·L-1(r=0.999 2)for chloramphenicol,123.2-1 232 mg·L-1(r=0.999 8)for salicylic acid.The average recoveries were 97.78%(RSD=2.69%),99.21%(RSD=1.30%),and 99.82%(RSD=2%).Conclusion This method is applicable to the control of related substances in chloramphenicol salicylic acid.
作者
王潆莘
赵衍辉
王雪
赵春杰
WANG Yingxin;ZHAO Yanhui;WANG Xue;ZAHO Chunjie(School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016,China)
出处
《沈阳药科大学学报》
CAS
CSCD
北大核心
2019年第8期693-698,共6页
Journal of Shenyang Pharmaceutical University
作者简介
王潆莘(1988-),女(回族),辽宁抚顺人,硕士研究生,E-mail syphu_wangyxin@163.com;通讯作者:赵春杰(1960-),男(汉族),吉林农安人,教授,博士,博士生导师,主要从事中药质量控制技术的研究工作,Tel.024-43520598,E-mail zcjjljj@sina.com。
