气相色谱法测定吡喹酮及片剂的残留溶剂

目的建立气相色谱法测定吡喹酮及片剂中的四种残留溶剂。方法采用DB-624(30 m×0.5 mm,0.5μm)色谱柱,柱温箱程序升温,采用FID检测器对乙醇和乙酸乙酯进行检测,采用ECD检测器对三氯甲烷和二氯甲烷进行检测。结果乙醇、乙酸乙酯、三氯甲烷、二氯甲烷四种残留溶剂分别在0.051 0⁵.102 4 mg·mL-1,0.050 05.102 4 mg·mL-1,0.050 0⁴.995 0 mg·mL-1,0.515 84.995 0 mg·mL-1,0.515 8⁵1.58μg·mL-1,5.008 051.58μg·mL-1,5.008 0⁵00.8μg·mL-1范围内呈良好的线性关系,相关系数均大于0.999 5。结论建立的气相色谱法简单、快速、准确,可用于吡喹酮原料及其制剂中的残留溶剂的检测,为国家评价性抽验工作提供技术支持。

Determination of residual solvents in praziquantel and its tablets by GC

Objective To establish an GC method for the determination of residual solvents in praziquantel and its tab- lets. Methods Agilent DB -624（30 m ×0. 5 mm × 0. 5 μm） column was used, the column temperature was pro- grammed. Ethanol and ethyl acetate were detected by FID, chloroform and methylene chloride were detected by ECD. Results The calibration curve of four residual solvents was linear in the concentration range of 0. 051 0- 5. 102 4 mg· mL-1 ,0. 050 0 -4. 995 0 mg· mL-1 ,0. 515 8 - 51.58 μLg· mL-1 ,5. 008 0- 500. 8 μg ·mL-1, respectively. The correlation coefficient r 〉 0. 999 5. Conclusion The method was simple, rapid, accurate and can be used for the determina- tion of residual solvents in praziquantel and its tablets.