Identification and determination of the photodegradation impurities in melphalan hydrochloride
10.11665/j.issn.1000-5048.20170514
- VernacularTitle:盐酸美法仑光降解杂质的鉴定与含量测定
- Author:
Xueqin CHEN
1
;
Fang GAO
;
Mingyi LIAO
;
Rui LI
;
Wei LI
;
Li DING
Author Information
1. 中国药科大学药物分析系
- Keywords:
melphalan hydrochloride;
photodegradation impurities;
structural identification;
hydrophilic interaction liquid chromatography(HILIC);
determination
- From:
Journal of China Pharmaceutical University
2017;48(5):590-595
- CountryChina
- Language:Chinese
-
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.
