Development and evaluation of a HILIC-MS method for the determination of amino acid and non-amino acid impurities in histidine

化学 甲酸铵 色谱法 组氨酸 亲水作用色谱法 氨基酸 甲酸 天冬氨酸 高效液相色谱法 生物化学
作者
Qun Xu,Fatkhulla K. Tadjimukhamedov
出处
期刊:Journal of Pharmaceutical and Biomedical Analysis [Elsevier BV]
卷期号:219: 114936-114936
标识
DOI:10.1016/j.jpba.2022.114936
摘要

Developing analytical methods to assure and control the quality of amino acids has long been a challenge for food ingredient, dietary supplement, and pharmaceutical industries due to the high polarity and the absence of chromophores in many amino acids; the situation worsens further by the lack of information of impurities that could potentially be introduced during the manufacturing processes. Herein we utilize a four-step strategy including impurity identification, method development, sample analysis, and targeted impurity detection and quantitation to demystify the impurity profiles of amino acids. The effectiveness of the approach is highlighted using histidine as an example. Analysis of histidine manufacturing and degradation processes led to the identification of 12 potential impurities of histidine, including amino acids (arginine, lysine, asparagine, aspartic acid, alanine, and glycine) and non-amino acid impurities (histamine, histidinol, 4-imidazoleacrylic acid, 4-imidazoleacetic acid, β-imidazolelactic acid, and urea). A HILIC method using Poroshell 120 HILIC-Z column (2.1 × 100 mm, 2.7 µm) and a mobile phase system consisting of ammonium formate buffer at pH 3.2 in water and 0.1% formic acid in acetonitrile coupled with a single quadrupole mass spectrometer was developed for the detection and quantitation of the proposed impurities. Evaluation of 11 commercial histidine samples using the developed method revealed distinct impurity profiles, as a fingerprint for each sample; seven of the 12 proposed impurities were detected in histidine samples tested. The developed method was evaluated in terms of specificity, linearity, range, accuracy, precision, and sensitivity (LOQ: 2.5–60.6 ng/mL) for its suitability for compendial applications. Given the high degree of overlap between the proposed and the detected impurities, the approach could be utilized to strengthen USP standards for controlling the quality of histidine. Extension of the strategy to the analysis of other amino acids is currently underway.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
沈ff完成签到,获得积分10
刚刚
qiqi完成签到,获得积分10
2秒前
肖肖发布了新的文献求助10
2秒前
JUdy发布了新的文献求助10
2秒前
自己完成签到,获得积分10
3秒前
常芹完成签到,获得积分10
3秒前
kkmedici关注了科研通微信公众号
3秒前
爱听歌的树叶完成签到,获得积分10
4秒前
5秒前
不宁不令完成签到,获得积分10
6秒前
圆滚滚完成签到,获得积分10
7秒前
8秒前
唐_完成签到,获得积分10
9秒前
桐桐应助彳亍而行采纳,获得10
9秒前
10秒前
qiqi发布了新的文献求助10
10秒前
11秒前
JUdy完成签到,获得积分10
12秒前
lll完成签到,获得积分10
13秒前
13秒前
13秒前
小艾完成签到,获得积分10
14秒前
英姑应助含糊采纳,获得10
14秒前
柒月小鱼完成签到 ,获得积分10
14秒前
奋斗雁山发布了新的文献求助10
14秒前
14秒前
15秒前
这样很OK发布了新的文献求助10
15秒前
tay完成签到,获得积分20
18秒前
韦谷兰发布了新的文献求助10
19秒前
QQQ发布了新的文献求助10
19秒前
Bio应助哈哈采纳,获得30
19秒前
20秒前
20秒前
kkmedici发布了新的文献求助30
20秒前
叮咚完成签到,获得积分10
21秒前
不想完成签到,获得积分10
21秒前
这样很OK完成签到,获得积分10
22秒前
GXWFDC完成签到,获得积分10
22秒前
西瓜汁完成签到,获得积分10
22秒前
高分求助中
A new approach to the extrapolation of accelerated life test data 1000
ACSM’s Guidelines for Exercise Testing and Prescription, 12th edition 500
‘Unruly’ Children: Historical Fieldnotes and Learning Morality in a Taiwan Village (New Departures in Anthropology) 400
Indomethacinのヒトにおける経皮吸収 400
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 370
基于可调谐半导体激光吸收光谱技术泄漏气体检测系统的研究 350
Robot-supported joining of reinforcement textiles with one-sided sewing heads 320
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 3988838
求助须知:如何正确求助?哪些是违规求助? 3531250
关于积分的说明 11252914
捐赠科研通 3269838
什么是DOI,文献DOI怎么找? 1804820
邀请新用户注册赠送积分活动 881943
科研通“疑难数据库(出版商)”最低求助积分说明 809028