论文部分内容阅读
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ShiseidoC_(18) 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。
Objective: To establish a HPLC method for the determination of chloramphenicol injection related substances (chloramphenicol diol and p-nitrobenzaldehyde) and content. METHODS: Shiseido C 18 MGⅡ (250 mm × 4.6 mm, 5 μm) was used as the mobile phase. The mobile phase consisted of methanol-0.01 mol·L -1 heptane sulfonate solution (potassium dihydrogen phosphate 6.8 g, 0.01 mol·L -1 sodium heptanesulfonate solution and dilute to 1000 ml, add 5 ml of triethylamine, mix and adjust pH to 2.5 with phosphoric acid (32:68); flow rate is 1.0 ml · Min ~ (-1); detection wavelength is 277 nm. Results: The linear ranges of chloramphenicol, chloramphenicol diol and p-nitrobenzaldehyde were 25.45-18.80 μg · ml -1 (r = 0.999 8), 7.95-63.60 μg · ml -1 1) (r = 0.999 7) and 1.86 ~ 7.44 μg · ml -1 (r = 0.999 9). The average recovery of chloramphenicol was 100.2% (RSD = 0.6%). Conclusion: The HPLC method established in this paper is accurate, reliable and specific. It can be used as a method for determination of related substances and contents of chloramphenicol injection.