高效液相色谱法测定盐酸金霉素溶液含量及有关物质  

Determination of Content and Related Substances of Chlortetracycline Hydrochloride Solution by HPLC

作　　者：马永贵[1] 李自明[1] 汪秋兰[1] 贺国芳[1] 

机构地区：[1]华中科技大学同济医学院附属同济医院药学部,武汉430030

出　　处：《医药导报》2012年第11期1485-1487,共3页Herald of Medicine

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.

关 键 词：金霉素 盐酸 含量测定 有关物质 色谱法 高效液相 

分 类 号：R978.1[医药卫生—药品] R927[医药卫生—药学]