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目的:建立以高效液相色谱-蒸发光散射(HPLC-ELSD)检测法测定小儿氨酚黄那敏颗粒中胆酸和猪去氧胆酸含量的方法。方法:采用高效液相色谱法,色谱柱为Capcell Pak MGⅡC18色谱柱(150 mm×4.6 mm,5μm),流动相:甲醇-1%冰醋酸溶液(70∶30),检测器为蒸发光散射检测器,漂移管温度为90℃,空气流速为1.8 L·min-1。结果:胆酸和猪去氧胆酸分别在进样量0.870~17.392μg和1.189~23.784μg范围内与峰面积的自然对数呈良好的线性关系,胆酸平均加样回收率为99.8%,RSD=1.5%(n=9);猪去氧胆酸平均加样回收率为100.6%,RSD=1.6%(n=9)。结论:本法简便可靠,适用于小儿氨酚黄那敏颗粒的质量控制。
Objective: To establish a HPLC-ELSD method for the determination of cholic acid and hyodeoxycholic acid in Pediatric Paracetamol and Granules. Methods: High performance liquid chromatography (HPLC) was performed on a Capcell Pak MG Ⅱ C18 column (150 mm × 4.6 mm, 5 μm) with a mobile phase of methanol-1% glacial acetic acid (70:30) The drift tube temperature was 90 ° C and the air flow rate was 1.8 L · min-1. Results: Cholic acid and hyodeoxycholic acid had a good linear relationship with the natural logarithm of the peak area in the range of 0.870-17.392μg and 1.189-23.784μg, respectively. The average recoveries of bile acids were 99.8%, RSD = 1.5% (n = 9). The average recovery of hyodeoxycholic acid was 100.6% with RSD = 1.6% (n = 9). Conclusion: This method is simple and reliable and is suitable for the quality control of paracetamol and Huangmin granule in children.