HPLC法测定羟苯甲_乙_丙_丁酯中的有关物质.pdf

2008 9 162 D rug Standards o f China 2008, vo l9 N o1 HPLC 1 1 1 2 袁耀佐 , 钱文 , 黄敏文 , 贺霞 ( 1, 2 10008; 2, 835000 : 建立快速准确的高效液相色谱法(H PLC 测定羟苯甲乙丙 丁 中的有关物质: 采用 C 18柱, 流动相为 甲醇- 1% 的冰醋酸( 6040 , 流速为 10 mLm in- 1, 检测波长 254 nm: 羟苯甲乙丙 丁的自身对照溶液在各供试品 溶液 025% ~ 4% 浓度范围内呈线性, 对羟基苯甲酸羟苯甲 羟苯乙 羟苯丙 羟苯 丁的检测限分别为 0506 5, 0493 5, 0490 0, 0497 5, 0543 0 ng, 5 组分之间的校正因子均在 08~ 13 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= -0072 7n+ 1217 9E-09, r= 0993 2: 该方法简单快捷, 灵敏度高, 同时适用 于羟苯甲乙丙 丁有关物质的测定 : H PLC; 有关物质: 羟苯甲 羟苯乙 羟苯丙 羟苯 丁 : 9212 : A : 1009- 3656( 2008 - 1- 62- 4 Determination ofRelated Substance inMethylparaben, Ethylparaben, Propylparaben, Buth- ylparaben byHPLC 1 1 1 2 Y uan Y ao-zuo , Q ian W en , H uang M in-w en , H e X ia ( 1Jiangsu P rov incial Institute f orDrug Control, Nanj ing 2 10008; 2Yili State Institutef orD rug Control, Yili 835000 ) Abstract bjective: T o estab lish a rap id and accura te m ethod for de term in ing re lated substance in m ethy lparaben, e thy lparaben, propy lparaben, buthy lparaben by HPLCM ethods:A C 18 Co lumn w as u sed, the m ob ile phase w as m etho l- 1% g lacid acetic acid ( 60 - 1 40 , the flow rate w as 10 mL m in , the detec tive w ave leng th w as 254 nmResults: The ca libration curves o fm e thy lparaben, eth- y lparaben, propy lparaben, buthylpa raben w ere a ll in good linea rity over the range o f 025% ~ 4% testing so lution concentration, the lmi it o f detection o f 4-hydroxybenzo ic ac id, m ethylparaben, ethy lpa raben, propy lparaben, bu thy lparaben w ere 0506 5, 0493 5, 0490 0, 0497 5, 0543 0 ng, respective ly, the co rrection facto rs am ong them w ere betw een 08~ 13, the response facto r ( a rea o f m ain peak / concentra tion o f e