盐酸赛洛唑啉中杂质A及其他有关物质测定方法的建立___
Determination of impurity A and other related substances in xylometazoline hydrochloride
分类号：
出版年·卷·期（页码）：2010,30 (1):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----摘要：-------------------------------------------------------------------------------------------
-----英文摘要：---------------------------------------------------------------------------------------
Objective:To establish a method for determination of impurity A and other related substances in xylometazoline hydrochloride.Methods:An HPLC method was established.The chromatographic column was C18,the mobile phase consisted of acetonitrile-0.1% triethylamine(adjusted to pH 5.0 with glacial acetic acid)(55∶45) at the flow rate of 1.0 mL·min-1,and the detection wavelength was 220 nm.Results:Impurity A made by destroying xylometazoline hydrochloride with NaOH solution,was used for ensuring its retention time in the chromatogram.The correction factor was 1.55.The LOD was 1 ng for impurity A(S/N=3.2) and 0.5 ng for xylometazoline hydrochloride (S/N=4.2);The LOQ was 10 ng for impurity A(S/N=11.2)and 5 ng for xylometazoline hydrochloride(S/N=12.8).Conclusion:Reference substance is avoided by the method using correction factor to determine impurity A.The method is accurate and available.
-----参考文献：---------------------------------------------------------------------------------------
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2 USP.313533
3 BP.20072187
4 LIN Da-kui(凌大奎).Related substances and its determination methods by HPLC(有关物质及其高效液相色谱法测定).Chin Pharm J(中国药学杂志),2000,35(8):567
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