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
2
;
Weixing NI
3
;
Ranzhi LIANG
3
;
Bin DI
4
;
Mengxiang SU
5
Author Information
1. School of Pharmacy，China Pharmaceutical University，Nanjing 210009，China
2. School of Pharmacy，China Pharmaceutical University，Nanjing 210009，China;Yangzhou Yiyang Pharmaceutical Co.，Ltd.，Jiangsu Yangzhou 225600，China
3. Yangzhou Yiyang Pharmaceutical Co.，Ltd.，Jiangsu Yangzhou 225600，China
4. School of Pharmacy，China Pharmaceutical University，Nanjing 210009，China;Key Laboratory of Drug Quality Control and Pharmacovigilance （China Pharmaceutical University ），Ministry of Education，Nanjing 210009，China;Key Laboratory for Research and Evaluation of Pharmaceutical Preparations and Excipients，National Medical Products Administration，Nanjing 210009，China
5. School of Pharmacy，China Pharmaceutical University，Nanjing 210009，China;Key Laboratory of Drug Quality Control and Pharmacovigilance （China Pharmaceutical University ），Ministry of Education，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.
