Content Determination of Potential Genotoxic Impurity Maleic Hydrazide in Azintamide
- VernacularTitle:阿嗪米特中潜在基因毒性杂质马来酰肼的含量测定
- Author:
Yuxin ZHAO
1
;
Bingzhe SUN
1
,
2
;
Weixing NI
2
;
Ranzhi LIANG
2
;
Bin DI
1
,
3
,
4
;
Mengxiang SU
1
,
3
Author Information
1. School of Pharmacy，China Pharmaceutical University，Nanjing 210009，China
2. Yangzhou Yiyang Pharmaceutical Co.，Ltd.，Jiangsu Yangzhou 225600，China
3. Key Laboratory of Drug Quality Control and Pharmacovigilance （China Pharmaceutical University ），Ministry of Education，Nanjing 210009，China
4. Key Laboratory for Research and Evaluation of Pharmaceutical Preparations and Excipients，National Medical Products Administration，Nanjing 210009，China
- Publication Type:Journal Article
- Keywords:
Maleic hydrazide;
Azintamide;
HPLC-FLD;
Genotoxic impurity
- From:
China Pharmacy
2021;32(18):2189-2193
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE：To establish a method for the content determination of potential genotoxic impurity maleic hydrazide in azintamide raw material. METHODS ：HPLC-FLD method was adopted. The determination was performed on Thermo Syncronis C18 column with mobile phase consisted of 0.2 mol/L acetic acid-methanol （gradient elution ）. The column temperature was set at 30 ℃，the excitation wavelength was 315 nm and emission wavelength was 389 nm. The flow rate was 1 mL/min，and the sample size was 20 μL. RESULTS：The blank solvent and azintamide did not interfere with the determination of maleic hydrazide. The linear range of maleic hydrazide was 19.5-300 ng/mL（r＝0.999 9）. The limit of detection was 4.5 ng/mL and the limit of quantification was 19.5 ng/mL. The recovery ranged from 98.79％ to 103.76％（RSDs were lower than 3.00％，n＝9）. RSDs of precision and stability （24 h）tests were no more than 5.63％，and those of durability tests were less than 2.00％（n＝6）. Maleic hydrazide was not detected in 3 batches of azinamide raw material. CONCLUSIONS ：The method is specific ，sensitive and accurate. It can be used for the trace determination of maleic hydrazide in azintamide or other matrix.
