首页|HPLC法测定赖氨酸维B12颗粒中香草醛的含量

HPLC法测定赖氨酸维B12颗粒中香草醛的含量

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目的:建立HPLC法测定赖氨酸维B12颗粒中香草醛含量的方法。方法:取赖氨酸维B12颗粒1。0 g,置10 mL刻度离心管中,加水1 mL溶解后,涡旋1 min,加甲醇至刻度后,继续涡旋1 min进行提取。采用Agi-lent C18(250 mm ×4。6 mm,5 μm)色谱柱,流动相为甲醇-水(35∶65),检测波长为277 nm。结果:本方法香草醛检出限为0。2 μg·g-1,浓度在1。962~49。04μg·mL-1的范围内呈线性关系(r=0。999 9),低、中、高三水平回收率在91。86%~101。61%之间,RSD为2。9%(n=9)。测定样品6批,A企业4批,香草醛含量在55。18~79。55μg。g-1,B企业和C企业均未检出。结论:该方法操作简便,结果可靠,可用于赖氨酸维B12颗粒中香草醛含量的测定。
Determination of vanillin in lysine and vitamin B12 granules by HPLC
Objective:To establish an HPLC method to determine of vanillin in lysine and vitamin B12 granules.Methods:1.0 g of lysine and vitamin B12 granules was put into a 10mL graduated centrifuge tube,1 mL of water was added to dissolve,vortex for 1 min,and methanol was added to the scale and vortex for 1 min for extraction.The samples were separated on a C18 column(250 mm × 4.6 mm,5 μm)with a mobile phase of methanol and water(35∶65)at ta flow rate of 1.0 mL·min-1.The detection wavelength was 277 nm.Results:The limit of detection of vanillin was 0.2 µg·g-1,and the concentration was linear in the range of 1.962-49.04 µg·mL-1(r=0.999 9).The recoveries of vanillin at low,medium and high levels were 91.86%-101.61%with RSD of 2.9%(n=9).6 batches of samples were determined,and the results showed that the vanillin content in 4 batches of enterprise A was 55.18-79.55 μg·g-1,and no vanillin was detected in enterprise B and enterprise C.Conclusion:The method is simple and reliable,and can be used for the rapid determination of vanillin in lysine and vitamin B12 granules.

lysine and vitamin B12 granulesvanillinHPLC methodpharmaceutical excipientflavoring agent

田海燕、刘娟、刘维彬、刘洪海

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德州市食品药品检验检测中心,山东德州 253000

赖氨酸维B12颗粒 香草醛 含量 HPLC法 辅料 矫味剂

2024

中国药品标准
国家药典委员会

中国药品标准

影响因子:0.372
ISSN:1009-3656
年,卷(期):2024.25(5)