CAJ | 학술논문

目的：：对药用辅料苯甲醇中有关物质检查方法进行研究。方法：采用气相色谱法, Agilent DB-wax 毛细管柱(0.32 mm ×30 m,1.8μm)；柱温：起始温度50℃,以5℃·min-1速率升温到220℃后,维持35 min；检测器为FID；进样口温度为200℃,检测器温度为310℃,并以气-质联用法对检测结果进行确证。结果：各杂质在一定范围内峰面积与浓度呈良好的线性关系(r≥0.9999),平均回收率为96.1%~102.7%,定量限为1.37~3.63 ng。样品中检出杂质甲苯、氯化苄、苯甲醛、苄醚。结论：本方法简便快捷、结果准确、方法可行,可用于药用辅料苯甲醇中有关物质的检测。
목적：：대약용보료분갑순중유관물질검사방법진행연구。방법：채용기상색보법, Agilent DB-wax 모세관주(0.32 mm ×30 m,1.8μm)；주온：기시온도50℃,이5℃·min-1속솔승온도220℃후,유지35 min；검측기위FID；진양구온도위200℃,검측기온도위310℃,병이기-질련용법대검측결과진행학증。결과：각잡질재일정범위내봉면적여농도정량호적선성관계(r≥0.9999),평균회수솔위96.1%~102.7%,정량한위1.37~3.63 ng。양품중검출잡질갑분、록화변、분갑철、변미。결론：본방법간편쾌첩、결과준학、방법가행,가용우약용보료분갑순중유관물질적검측。
To establish a GC method to determine the related substances in pharmaceutical excipient benzyl alcohol. Methods:A GC method was used with an Agilent DB-wax eapillary column(0. 32 mm × 30 m,1. 8 μm)and programming temperature. The initial temperature was 50℃, and then raised to 220℃ with a rate of 5℃·min-1 and maintained for 35min. The detector was FID. The temperature of the injection port was 200℃,and the detector temperature was 310℃. The results were confirmed by GC-MS. Results:Within a certain range,the peak area and concentration of every impurity had a good linear relationship (r≥0. 999 9). The recovery was between 96. 1% and 102. 7%. The quantitative limit was between 1. 37-3. 63 ng. Toluene, benzyl chloride, benzalde-hyde and benzyl ether were found out in the samples. Conclusion:The method is accurate and convenient, and suitable for the quanti-tative determination of related substances in pharmaceutical excipient benzyl alcohol.