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目的建立测定硝酸布康唑原料药中乙酸乙酯、三氯甲烷、N,N-二甲基甲酰胺3种有机溶剂残留量的分析方法。方法采用毛细管气相色谱法,程序升温,检测器:FID;检测器温度:250℃;进样器温度:200℃;载气:氮气;顶空进样。结果在上述色谱条件下,乙酸乙酯,三氯甲烷,N,N-二甲基甲酰胺分别在0.066~0.588,0.062~0.556,0.896~8.061μg·m L-1质量浓度范围内呈良好线性关系。平均回收率分别为99.18%,102.84%,98.71%,RSD分别为3.87%,4.33%,3.71%。结论该检测方法灵敏、准确、可靠,可用于硝酸布康唑原料药的质量控制。
OBJECTIVE To establish a method for the determination of three organic solvents, ethyl acetate, trichloromethane and N, N-dimethylformamide in the raw material of buconazole nitrate. Methods capillary gas chromatography, temperature programmed, detector: FID; detector temperature: 250 ℃; injector temperature: 200 ℃; carrier gas: nitrogen; Results Under the above chromatographic conditions, ethyl acetate, trichloromethane and N, N-dimethylformamide showed good linearity in the range of 0.066-0.588, 0.062-0.556 and 0.896-8.061 μg · m L-1, respectively relationship. The average recoveries were 99.18%, 102.84% and 98.71%, respectively. The RSDs were 3.87%, 4.33% and 3.71%, respectively. Conclusion The method is sensitive, accurate and reliable and can be used for the quality control of buconazole nitrate drug substance.