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目的建立人工麝香口崩片中麝香酮的含量测定方法。方法气相色谱法,样品以甲醇超声提取,Varian-3800型气相色谱仪,色谱柱:Cp-sil 8 cb low bleed/ms(30 m×0.25 mm,0.25μm);程序升温:160℃～250℃;检测器:氢火焰离子化检测器(FID),280℃,进样口温度260℃;载气为N_2,流速1.06mL/min,分流比10:1。结果麝香酮在56.7～226.8μg/mL线性良好(r=0.999 7),平均回收率100.14%,RSD=1.68%。结论本方法简便,快速、准确、重现性好,可作为本制剂的质量控制方法。
Objective To establish a method for determination of musk ketone in artificial musk orally disintegrating tablets. Methods Gas chromatography was used. The samples were extracted with methanol by ultrasonication using a Varian-3800 GC with a chromatographic column: Cp-sil 8 cb low bleed / ms (30 m × 0.25 mm, 0.25 μm) ; Detector: hydrogen flame ionization detector (FID), 280 ℃, inlet temperature 260 ℃; carrier gas N_2, flow rate 1.06mL / min, split ratio 10: 1. Results Musk ketone had good linearity (r = 0.999 7) at 56.7 ~ 226.8 μg / mL with an average recovery of 100.14% and RSD = 1.68%. Conclusion The method is simple, rapid, accurate and reproducible. It can be used as the quality control method of this preparation.