摘要
目的：建立快速、准确的高效液相色谱法（HPLC）测定羟苯甲、乙、丙、丁酯中的有关物质。方法：采用C18柱，流动相为甲醇-1％的冰醋酸（60：40），流速为1．0mL·min^-1，检测波长254nm。结果：羟苯甲、乙、丙、丁酯的自身对照溶液在各供试品溶液0．25％～4％浓度范围内呈线性，对羟基苯甲酸、羟苯甲酯、羟苯乙酯、羟苯丙酯、羟苯丁酯的检测限分别为0．5065。0．4935，0．4900，0．4975，0．5430ng，5组分之间的校正因子均在0．8～1．3范围内，5组分的响应因子（峰面积／供试品的浓度，y）与其化学结构侧链上含碳数（n）成正比，Y=-0．0727n＋1．2179E-09，r=0．9932。结论：该方法简单、快捷，灵敏度高，同时适用于羟苯甲、乙、丙、丁酯有关物质的测定。
Objective： To establish a rapid and accurate method for determining related substance in methylparaben, ethylparaben, propylparaben, buthylparaben by HPLC. Methods：A C18 Column was used,the mobile phase was methol -1% glacid acetic acid （60： 40） , the flow rate was 1.0 mL · min^-1, the detective wavelength was 254 nm. Results： The calibration curves of methylparaben, ethylparaben, propylparaben, buthylparaben were all in good linearity over the range of 0. 25% -4% testing solution concentration, the limit of detection of 4-hydroxybenzoic acid, methylparaben, ethylparaben, propylparaben, buthylparaben were 0. 506 5,0. 493 5,0. 490 0,0. 497 5,0. 543 0 ng, respectively, the correction factors among them were between 0. 8 - 1.3, the response factor （ area of main peak/concentration of each component , Y） of them is direct proportional to the number of carbon in their side chain （n）, the regression equation was Y = -0. 072 7n ＋ 1. 217 9E -09 ,r =0. 993 2. Conclusion： this method is simple, rapid and sensitive, it is suitable to the determination of related substance in methylparaben, ethylparaben, propylparaben and buthylparaben, simultaneously.
出处
《中国药品标准》
CAS
2008年第1期62-65,共4页
Drug Standards of China
