反相高效液相色谱法测定氯霉素滴眼液中氯霉素及有关物质的含量

目的采用反相高效液相色谱（RP—HPLC）法测定氯霉素滴眼液中氯霉素的含量及有关物质中二醇物和对硝基苯甲醛的含量。方法采用Phenomsil C18柱（250mm×4．6mm，5μm），以甲醇-水-10％四丁基氢氧化铵溶液（350：635：15）为流动相，流速为1．0mL／min，检测波长为272nm。结果质量浓度线性范围氯霉素为40．0～200．0μg／mL（r=0．9997），二醇物为3．0～15．0μg／mL（r=0．9994），对硝基苯甲醛为1．0～5．0μg／mL（r=0．9997）；方法的平均回收率为99．24％，RSD=1．08％（n=6）。结论RP—HPLC法分离效果好，灵敏度高，重现性好，结果准确可靠。

Determination of Chlorampenicol and Related Substance in Chlorampenicol Eye Drops with RP- HPLC Method

Objective To develop a quantitative method for the determination of chlorampenicol and related substances, such as glycols and p- nitrobenzaldehyde, in chlorampenicol eye drops by RP- HPLC. Methods RP- HPLC method was used with Phenomsil- C18 （250 mm × 4.6 mm, 5 μm） as the stationary phase and methanol-water-10% tetrabutyl ammonium hydroxide （350：635：15） as the mobile phase. The detection wavelength was 272 nm and the flow rate was 1.0 mI,/min. Results Chlorampenicol, glycols, and p-nitrobenzaldehyde respectively showed a good linear relationship in the following ranges of concentration： 40. 0 -200. 0 μg/mL （r=0. 999 7）, 3.0- 15.0 μg/mL （r =0.999 4）, 1. 0 -5.0 μg/mL （ r = 0. 999 7）, and the average recovery rate was obtained as 99. 24%, RSD = 1.08% （ n = 6）. Conclusion The method with good separation is sensitive, reproducible, accurate and reliable.