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目的:建立HPLC测定环吡酮胺搽剂中环吡酮胺的含量。方法:采用Agilent ZORBAX SB-C_(18)色谱柱(250 mm×4.6 mm,5μm),以甲醇:乙腈:水相(含25 mmol·L~(-1)枸缘酸和2.5 mmol·L~(-1)EDTA,20%NaOH调pH 7.0)(32:18:50)为流动相,检测波长为307 nm,流速为1 ml·min~(-1),柱温30℃,进样量20μl。结果:有关物质含量为0.58%,环吡酮胺在20～200mg·L~(-1)范围内线性关系良好(r=0.999 6),平均回收率为101.23%(RSD=1.88%,n=9)。结论:本法准确、可靠、重复性好,可用于控制环吡酮胺搽剂的质量和有关物质的测定。
Objective: To establish an HPLC method for the determination of ciclopirox olamine in ciclopirox olamine. METHODS: The mobile phase consisted of methanol: acetonitrile: water (containing 25 mmol·L -1 of citric acid) and 2.5 mmol·L ~ (-1) of citric acid on a ZORBAX SB-C 18 column (250 mm × 4.6 mm, (-1) EDTA and 20% NaOH (pH 7.0) (32:18:50) was used as the mobile phase. The detection wavelength was 307 nm, the flow rate was 1 ml · min -1, 20 μl. Results: The content of ciclopirox olamine in the range of 20 ~ 200 mg · L ~ (-1) was 0.58% (r = 0.999 6) with the average recoveries of 101.23% (RSD = 1.88%, n = 9). Conclusion: This method is accurate, reliable and reproducible. It can be used to control the quality and related substances of ciclopirox olamine liniment.