Content Determination of Potential Genotoxic Impurity Maleic Hydrazide in Azintamide
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Content Determination of Potential Genotoxic Impurity Maleic Hydrazide in Azintamide
China PharmacyVol. 32, Issue 18, (2021)
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Published:2021,
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ZHAO Yuxin, SUN Bingzhe, NI Weixing, et al. Content Determination of Potential Genotoxic Impurity Maleic Hydrazide in Azintamide. [J]. China Pharmacy 32(18).(2021)
DOI:
ZHAO Yuxin, SUN Bingzhe, NI Weixing, et al. Content Determination of Potential Genotoxic Impurity Maleic Hydrazide in Azintamide. [J]. China Pharmacy 32(18).(2021)DOI:
Content Determination of Potential Genotoxic Impurity Maleic Hydrazide in Azintamide
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.