摘要
目的:建立高效液相色谱测定小儿氨酚烷胺颗粒中人工牛黄含量的方法,进而评价该品种中人工牛黄胆红素的现状。方法:采用高效液相法,色谱柱为C18(4.6mm×250mm,5μm),流动相为甲醇-三氯甲烷-0.1%磷酸(88:6:6),检测波长为449nm,流速为0.8mL/min,柱温为30℃。结果:胆红素在该色谱条件下系统适应性符合要求,胆红素在0.6~24μg/mL的范围内呈良好的线性关系,回归方程为:Y=50776X-7032.1R=0.9997(n=6);26批次样品中有3批胆红素含量低于理论最小值。结论:该色谱法适用于小儿氨酚烷胺颗粒中人工牛黄胆红素的测定;建议标准加入人工牛黄含量的考察。
Objective:To establish an HPLC method for determination of the content of the calculus bovis artifactus in pediatric paracetamol and amantadine hydrochloride granules,and analyze the quality of calculus bovis artifactus.Methods:HPLC was used,and the chromatographic conditions were as follows:C18 chromatographic column,methanol-Trichloromethane-0.1% phosphoric acid(88:6:6)as mobile phase,detection wavelength at 449 nm,and flow rate was 0.8 mL/min,column temperature set at 30 ℃.Results:The system adaptability of bilirubin in the chromatographic condition was satisfactory,and the bilirubin had a good linear relationship in the range of 0.6~24μg/mL,and the regression equation was:Y=50776 X-7032.1 R=0.9997(n=6).In the 26 batches,3 batches of bilirubin contents were lower than the theoretical minimum.Conclusion:This method is applicable to the determination of calcu-lus bovis artifactus bilirubin in pediatric paracetamol and amantadine hydrochloride granules.It was recommended to add the determination of calculus bovis artifactus.
出处
《河北省科学院学报》
CAS
2017年第4期66-69,共4页
Journal of The Hebei Academy of Sciences
基金
河北省食品药品监督管理局食品药品安全科技项目(PT2014020)
关键词
小儿氨酚烷胺颗粒
人工牛黄
胆红素
Pediatric paracetamol and amantadine hydrochloride granules
Calculus bovis artifactus
Bilirubin
