高效液相色谱法测定酚麻美敏片中对氨基酚含量  

Content Determination of P-Aminophenol in Fenma Meimin Tablets by HPLC

作　　者：杨大龙 严相平 冷柏榕 Yang Dalong;Yan Xiangping;Leng Borong(Jiangsu Provincial Institute of Materia Medica,Nanjing,Jiangsu,China 210009)

机构地区：[1]江苏省药物研究所有限公司,江苏南京210009

出　　处：《中国药业》2018年第19期17-19,共3页China Pharmaceuticals

摘　　要：目的建立测定酚麻美敏片中有关物质对氨基含量酚的高效液相色谱(HPLC)法。方法色谱柱采用Cosmosil C8柱(250 mm×4. 6 mm,5μm),流动相为磷酸盐缓冲液(磷酸氢二钠8. 95 g,磷酸二氢钠3. 9 g,加水溶解至1 000 m L,加10%四丁基氢氧化铵12 m L)-甲醇(95∶5),检测波长为245 nm。结果对氨基酚质量浓度在0. 04~19. 88μg/m L范围内与峰面积线性关系良好,r=0. 999 4 (n=6);检测限为0. 2 ng;平均回收率为99. 83%,RSD为0. 70%(n=9)。结论该方法简便、快速、灵敏度高,可用于酚麻美敏片中对氨基酚的含量测定。Objective To establish an HPLC method for the content determination of the related substances p-aminophenol in Fenma Meimin Teblets. Methods The Cosmosil C8 column（250 mm ×4.6 mm, 5 μm） was adopted with the mobile phase of phosphate buffer solution（disodium hydrogen phosphate 8.95 g, sodium dihydrogen phosphate 3.9 g, dissolved in water to 1 000 mL, inside 10% tetra-butyl ammonium hydroxide 12 mL-methanol（95：5） at the detection wavelength of 245 nm. Results The p-aminophenol had good linear relationship in the range of 0.04- 19.88 μg/mL, r=0. 999 4（n =6）, and the limit of detection was 0. 2 ng, the average recovery was 99.83%, and RSD was 0.70% （n =9）. Conclusion The method is simple, rapid and sensitive, which can be used for content determine of p-aminophenol in Fenma Meimin Tablets.

关 键 词：酚麻美敏片 对乙酰氨基酚 有关物质 对氨基酚 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学] R971.1