Objective To establish a melhod for simultaneous determination of melronidazole, clindamycin phosphale and Irelinoin by HPLC. Methods The chromalographic analysis was carried oul on a Venusil XBP-C18( L) column< 4. 6 mm x250 mm, 5μm) with ace-lonilrile and polassium dihydrogen phosphale buffer solulion(the Ph value was adjusled lo 3.0 by phosphoric acid) as the mobile phase by gradienl elulion al a flow rale of 1.0 ml- min~ .The column lemperalure was 30℃ and sample size was 20μl. The deleclion wave-lenglh of clindamycin phosphale is 214 nm, meanwhile the wavelength of melronidazole and Irelinoin were sel al 350 ran. Results The good resolution between peaks of main drugs and of ihe adjacent purity was larger than 1.5. Linear regression equation of melronidazole, clindamycin phosphale and Irelinoin were Y = 30. 33X - 3. 25(r= 0.999 6) , Y= 3. 825 SX + 15. 55(r =0. 999 8), Y = 149.43 X- 12. 06 ( r = 0. 999 9) , and they were obtained in the range of 50 - 350, 60 - 420, 0. 1 - 100 mg·L-1. The average recoveries were 99. 90% , 99. 71%, 99. 02%. Conclusion The HPLC melhod shows a good separation, reproducibilily and accuracy. It can be used lo determine melronidazole, clindamycin phosphate and Iretinoin.%目的 建立HPLC法同时测定复方痤疮凝胶中甲硝唑、克林霉素磷酸酯、维A酸含量的方法.方法 色谱柱:Venusil XBP(L)C18柱(4.6 mm ×250 mm,5 μm)为固定相,以磷酸盐缓冲液(取15 mol·L-1磷酸二氢钾溶液,磷酸溶液调节pH值至3.0)-乙腈为流动相进行梯度洗脱;进样量:20 μl;柱温:30℃;流速:1.0 ml·min-1;紫外检测波长:克林霉素磷酸酯214 nm,甲硝唑和维A酸350 nm.结果 主成分峰与相邻杂质峰分离度大于1.5.甲硝唑、克林霉素磷酸酯和维A酸回归方程依次分别为:Y=30.33X-3.25(r=0.999 6);Y=3.825 8X+15.55(r=0.999 8);Y=149.43X-12.06(r=0.999 9);线性范围分别为:50～350、60～420、0.1～100 mg·L-1.平均回收率为:99.90%、99.71%、99.02%.结论 该法操作方便,结果准确可靠,可用于复方痤疮凝胶中的甲硝唑、克林霉素磷酸酯、维A酸的含量测定.
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