快速测定婴配乳粉和特医食品中泛酸的UPLC-MS法及其与国标方法等效性分析

A rapid test for the determination of pantothenic acid in powdered infant milk and special medical food and its equivalence to the national standard method

建立了超高效液相色谱串联质谱法(UPLC-MS)测婴幼儿配方乳粉和特殊医学用途配方食品中泛酸的快速方法。采用pH=3.8~4.0的乙酸铵缓冲液沉淀分离蛋白,样液经稀释、过膜后直接注入UPLCMS系统中,内标定量。该方法泛酸有着良好的峰型和响应,线性范围内线性关系良好、方法精密度良好,对于婴幼儿配方乳粉,其RSD=2.01%,对于特殊医学用途配方食品,其RSD=1.01%,该方法正确度良好,婴幼儿配方乳粉回收率为97.72%~102.42%,特医配方乳粉回收率为94.52%~106.28%。该方法检出限低(LOD=9μg/100g)、特异性好、稳定性和再现性好,检测过程简单快捷,能适用于婴幼儿配方乳粉和特殊医学用途配方食品中泛酸的测定。同时该方法经过与相应国标检测方法第二法进行统计学分析,发现与国标法并无显著性差异,即该方法与国标法等效。

A rapid test for the determination of pantothenic acid in powered infant formula and special medical purposes formula by ultra high performance liquid chromatography-mass spectrometry(UPLC-MS)was established.The separated protein was precipitated with ammonium acetate buffer(pH=3.8~4.0).The sample solution was diluted and then injected into UPLC-MS system for analysis,and quantified by internal standard method.Under the established testing conditions,pantothenic acid had a good peak shape and response,and a good linear relationship within the linear range.The method was precise(for infant formula milk,the RSD was 2.01%,and for special medical purposes formula,RSD was 1.01%)and accurate(for powdered infant formula,the recovery rate was 97.72%~102.42%,and for powdered special medical purposes formula,the recovery rate was 94.52%~106.28%).The method had a low detection limit(LOD=9μg/100g),good specificity,stability and reproducibility.The detection process was simple and fast.It could be used for the determination of pantothenic acid in powder infant formula and special medical purposes formula.Finally,through statistical analysis of the national standard,no significant difference from the national standard method was found.Therefor,the method was equivalent to the national standard method.