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HPLC法测定雷美替胺与其对映异构体的含量.pdf


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山 东 化 工
      huo Jing Sun Tong
, , ,
(Suqian Institutes for Drug and Food Control,Suqian  223800,China)
Abstract
:Objective: To establish a method for the determination of ramelteon and its enantiomers in rametidine related
preparations by liquid chromatography. Method: An DAICEL AD - H ( 4. 6 mm × 250 mm,5 μm) was used, the mobile phase
consisted of n-hexane-ethanol- methanesulfonic acid(900 ∶ 100 ∶ 0.1),the column temperature was 25 ℃ ,the flow rate was

1.0 mL / min, the detection wavelength was 220 nm,the sample volume was 10 μL.Results:The linear relationship was good ( >
0.999) in the range of 0.20~ 20.20 μg / mL and 0.20 ~ 19.67 μg / mL for ramelteon and its enantiomer,respectively.The limit of
RSD
quantitation of 2 ng / mL. The average recovery was 99. 00% and 99. 02%, respectively. The was 1. 01% and 0. 33%,

respectively( = 9).Conclusion:This method has strong specificity,high sensitivity

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  • 时间2022-05-16