UPLC法测定小儿氨咖黄敏颗粒中对乙酰氨基酚、咖啡因和马来酸氯苯那敏的含量

Simultaneous determination of acetaminophen,trimethylxanthine and chlorphenamine maleate in Xiaoer′ankahuangmin Granules by UPLC

目的使用超高效液相色谱(UPLC)法建立测定小儿氨咖黄敏颗粒中3种西药成分含量的方法。方法色谱柱为Acquity UPLC~BEH C18柱(7.5cm×0.21cm,1.7μm);柱温为35℃;流动相为0.03mol·L-1磷酸氢二铵溶液-乙腈(88∶12);检测波长为214nm。结果线性范围为:对乙酰氨基酚0.149~1.489μg,r=0.999 8;咖啡因0.010~0.101μg,r=0.999 4;马来酸氯苯那敏0.005~0.082μg,r=0.999 9。平均回收率:对乙酰氨基酚99.3%,RSD=0.42%;咖啡因98.8%,RSD=0.50%;马来酸氯苯那敏99.5%,RSD=0.78%。结论相对于现行药品执行标准中的含量测定方法,UPLC法测定3种西药含量更准确、方便,可较好地控制小儿氨咖黄敏颗粒的质量。

To establish an accurate method for the determination of 3 chemical ingredients in Xiaoer/ankahuangmin Gran-ules by UPLC. The analytical column was Acquity UPLC？ BEH C18 （7. 5 cm X 0. 21 cm, 1.7 jnm）,with the column tem-perature of 35 °C , 0. 03 mol＊ L 1 of （NH4 ）2 HP04-acetonitrile （88：12） was adopted to compose the mobile phase. The UV detec-tion wavelength was 214 nm. The linear ranges of acetaminophen, trimethylxanthine and chlorphenamine maleate were at0. 149-1. 489 （r=0. 999 8） ,0. 010-0. 101 （r=0. 999 4） and 0. 005-0. 082 pg （r=0. 999 9） ,respectively. The average recoveries of acetaminophen, trimethylxanthine, chlorphenamine maleate were 99. 3% （ RSD = 0. 42 % ）, 98. 8 % （ R S D = 0 . 5 0 % ） and 99. 5 % （RSD = 0. 78%） respectively. Compared with the current implementing standard, the determination method by UPLCwas more accurate and convenient, which could better control the quality of Xiaoer/ankahuangmin Granules.