高效液相色谱法测定复方氯甲霜中氯霉素及甲硝唑的含量

Quality specification standard of Chloramphenicol Metronidazole Cream

目的对复方氯甲霜的质量标准进行再提高研究。方法色谱柱为Agi Lent XDB-C_(18)(150 mm×4.6 mm,5μm);流速为1 m L·min^(-1);柱温为30℃;进样量为10μL;氯霉素的流动相为甲醇-庚烷磺酸钠缓冲溶液(32∶68);紫外检测波长为277nm;甲硝唑的流动相为甲醇-水(20∶80);紫外检测波长为320 nm。结果氯霉素、甲硝唑进样量分别在5.56~111.2,26.02~260.2 mg·L^(-1)浓度范围内与峰面积呈良好的线性关系,r分别为1.000 0和0.999 6(n=6);平均回收率分别为103.8%,99.6%,RSD分别为1.73%和0.43%(n=9)。结论该方法简便快速、准确、重复性好,可用于该制剂中氯霉素及甲硝唑的含量测定。

Objective To improve quality standards of Chloramphenicol Metronidazole Cream. Methods Chloramphenicol andmetronidazole were assayed by HPLC. Agi Lent XDB-C18（ 150 mm × 4. 6 mm,5 μm） was used at the rate of 1. 0 m L·min^-1. The injection volume was 10 μL and the column temperature was set at 30 ℃. 277 nm and 320 nm were selected asthe detection wavelengths forchloramphenicol and metronidazole respectively,and themobile phasesweremethanol-sodiumheptanesulfonate（ 32∶ 68） forchloramphenicol and methanol-water（ 20 ∶ 80） formetronidazole,respectively. Results A good linearrelationship was established between the peak response and the concentration of chloramphenicol and metronidazole over the range of 5. 56 - 111. 2 mg·L^-1（ r = 1. 000 0） and 26. 02- 260. 2 mg· L^-1（ r = 0. 999 6） respectively. The mean recoveries of chloramphenicol and metronidazole were103. 8 %（ RSD =1. 73%） and 99. 6 %（ RSD = 0. 43%）,respectively. Conclusion The method is simple,accurate and repeatable,which can be used for the determination of Chloramphenicol Metronidazole Cream.