中国药科大学学报2017，Vol.48Issue(5)：590-595,6.DOI:10.11665/j.issn.1000-5048.20170514
盐酸美法仑光降解杂质的鉴定与含量测定
Identification and determination of the photodegradation impurities in melphalan hydrochloride
陈雪琴 1高芳 2廖明毅 2李瑞 2李薇 2丁黎2
作者信息
- 1. 中国药科大学药物分析系,南京210009
- 2. 江苏先声药业有限公司,南京210042
- 折叠
摘要
Abstract
This study was aimed to identify the photodegradation impurities (PD1 and PD2) in melphalan hydrochloride and establish a method for determining PD1 and PD2.The structures of the photodegradation impurities were inferred by LC-MS/MS.The impurities were confirmed by comparing with synthesized impurities.An HILIC method was established to determine PD1 and PD2.The method was carried out on an Atlantis HILIC column(4.6 mm × 150 mm,3 μm) with the mobile phase consisting of 0.1 mol/L ammonium formate (adjusted to pH 3.0 with formic acid) and acetonitrile (13∶ 87) at the flow rate of 1.0 mL/min.The column temperature was 35 ℃.The detection wavelength was 260 nm.PD1 and PD2 were characterized as 4-amino-L-phenylalanine hydrochloride and 4-(2-chloroethyl) amino-L-phenylalanine hydrochloride,respectively.Melphalan hydrochloride,PD1 and PD2 were separated completely under the HILIC condition.The established HILIC method can be used to determine the photodegradation impurities.关键词
盐酸美法仑/光降解杂质/结构鉴定/亲水作用色谱/含量测定Key words
melphalan hydrochloride/photodegradation impurities/structural identification/hydrophilic interaction liquid chromatography(HILIC)/determination分类
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陈雪琴,高芳,廖明毅,李瑞,李薇,丁黎..盐酸美法仑光降解杂质的鉴定与含量测定[J].中国药科大学学报,2017,48(5):590-595,6.
