HPLC法测定氯霉素注射液的有关物质和含量

目的:建立HPLC法测定氯霉素注射液的有关物质（氯霉素二醇物和对硝基苯甲醛）和含量。方法:色谱柱采用ShiseidoC₁₈ MGⅡ（250 mm×4.6 mm,5μm）;流动相为甲醇-0.01 mol·L^-1庚烷磺酸钠溶液(取磷酸二氢钾6.8 g,用0.01 mol·L^-1庚烷磺酸钠溶液并稀释至1 000 ml,再加三乙胺5 ml,混匀,用磷酸调节pH至2.5)（32:68）;流速为1.0 ml·min^-1;检测波长为277 nm。结果:氯霉素、氯霉素二醇物、对硝基苯甲醛的线性范围分别为25.45～178.12μg·ml^-1（r=0.999 8）,7.95～63.60μg·ml^-1（r=0.999 7）和1.86～7.44μg·ml^-1（r=0.999 9）。氯霉素平均回收率为100.2%（RSD=0.6%）。结论:本文建立的高效液相色谱法结果准确可靠,专属性好,可作为氯霉素注射液有关物质和含量的测定方法。

Determination of Related Substances and Content of Chloramphenicol Injection by HPLC

Objective ： To establish an HPLC method for the determination of related substances and content of ehloramphenicol injection. Method： A Shiseido C18 MG Ⅱ column （250 mm ×4. 6 mm,5 μm） was used. The mobile phase consisted of methanol-0. 1 mol · L ^- 1 1 -heptanesulfonic acid sodium solution （ including 0. 1 mol· L ^- 1 1 -heptanesulfonie acid sodium, 0. 5 mol· L ^- 1 potassium dihydrogen and 0. 5% diethylamine, adjusting pH to 2. 5 with phosphoric acid） （ 32 ： 68 ）, the flow rate was 1. 0 ml· min^ - 1 and the detection wavelength was 277 nm. Result： The linear range of chloramphenicol, 2-amino-1- （4-nitrophenyl）-1,3-propanediol and 4-nitrobenzaldehyde was 25.45-178.12 μg· ml ^- 1 （ r = 0. 999 8 ）, 7. 95453.60 μg· ml ^- 1 （ r = 0. 999 7 ） and 1.86 - 7.44 μg· ml ^- 1 （ r = 0. 999 9 ）, respectively. The average recovery of chloramphenicol was 100. 2% （ RSD = 0. 6% ）. Condusion： The method is accurate, reliable and suitable for the determination of related substances and content of chloramphenicol injection.