摘要
目的建立测定盐酸金霉素溶液含量和有关物质的高效液相色谱法。方法采用C18色谱柱(pH适应范围>8,4.6 mm×250 mm,5μm),以0.05 mol.L-1草酸铵溶液-二甲基甲酰胺-0.1 mol.L-1磷酸氢二铵溶液(56∶40∶4)(用氨试液调节pH至8.3)为流动相;流速0.9 mL.min-1;柱温:40℃;检测波长:370 nm;进样量:10μL。结果盐酸金霉素在0.006~0.096μg.mL-1范围内线性关系良好,r=0.999 8,平均回收率分别为100.5%(RSD=0.36%),98.7%(RSD=1.04%),100.9%(RSD=0.48%)(n=3),检测限为38.2 ng。结论该方法测定快速、简单、准确,灵敏度高,适用于盐酸金霉素溶液的有关物质和含量测定。
Objective To establish a HPLC method for determination of the content and related substances of chlortetracycline hydrochloride solution.Methods The HPLC system consisted of C18 column(pH8,4.6×250 mm,5 μm),0.05 mol·L-1 ammonium oxalate solution-dimethylformamide-0.1 mol·L-1 ammonium dibasic phosphate solution(56:40:4)(pH being adjusted to 8.3 with ammonia solution) as mobile phase,the flow rate was 0.9 mL· min-1.Detection wavelength was set at 370nm,the injection volume was 10 μL and column temperature was 40℃.Results The calibration curve was linear in the range of 0.006~0.096 mg·mL-1(r = 0.999 8),the average recoveries were 100.5%(RSD=0.36%),98.7%(RSD=1.04%),100.9%(RSD=0.48%)(n=3),respectively.The limit of detection was 38.2 ng.Conclusion The method was rapid,simple,accurate,sensitive and suitable for the content and related substances determination of chlortetracycline hydrochloride solution.
出处
《医药导报》
CAS
北大核心
2012年第11期1485-1487,共3页
Herald of Medicine
关键词
金霉素
盐酸
含量测定
有关物质
色谱法
高效液相
Chlortetracycline hydrochloride solution
Determination of content
Related substances
HPLC
Chromatography