论文部分内容阅读
目的:建立HPLC法同时快速测定辅酶Q_(10)维生素E软胶囊中辅酶Q_(10)和维生素E的含量。方法:以无水乙醇为提取溶剂对样品进行超声提取;选用Accucore C_(18)(150 mm×2.1 mm,2.6μm)色谱柱,以无水乙醇-甲醇(7∶13)为流动相,流速0.4mL·min~(-1),柱温38℃,检测波长280 nm。结果:样品中辅酶Q_(10)和维生素E在6 min内得到很好的分离,质量浓度分别在0.050~0.502和0.100~0.801 mg·mL~(-1)范围内呈良好线性(r=0.999 9);辅酶Q_(10)高、低添加水平的平均回收率(n=3)分别为90.6%和98.3%,RSD分别为2.9%和4.0%;维生素E高、低添加水平的平均回收率(n=3)为98.9%和95.7%,RSD分别为3.1%和2.6%。3批样品中辅酶Q_(10)含量分别为103、102和105 mg·g~(-1),维生素E含量分别为70.7、71.3和71.2 mg·g~(-1)。结论:本文建立的方法经方法学验证,可用于辅酶Q_(10)维生素E软胶囊的质量控制。
OBJECTIVE: To establish an HPLC method for the simultaneous determination of coenzyme Q_ (10) and vitamin E in Coenzyme Q_ (10) vitamin E soft capsules. Methods: The samples were extracted by ultrasonic with absolute ethanol as the extraction solvent. The samples were separated on a Accucore C18 (150 mm × 2.1 mm, 2.6 μm) column with anhydrous ethanol-methanol (7:13) 0.4mL · min ~ (-1), column temperature 38 ℃, detection wavelength 280 nm. RESULTS: Coenzyme Q_ (10) and vitamin E were well separated in 6 min, and the linearity was within the range of 0.050-0.502 and 0.100-0.801 mg · mL -1 (r = 0.999 9). The average recoveries (n = 3) of coenzyme Q_ (10) at high and low levels were 90.6% and 98.3%, respectively, with RSDs of 2.9% and 4.0%, respectively. (n = 3) were 98.9% and 95.7% with RSDs of 3.1% and 2.6%, respectively. The contents of coenzyme Q_ (10) in the three batches of samples were 103, 102 and 105 mg · g -1, respectively, and the contents of vitamin E were 70.7, 71.3 and 71.2 mg · g -1, respectively. Conclusion: The method established in this paper is validated by methodology and can be used for the quality control of coenzyme Q_ (10) vitamin E soft capsule.