GC法测定紫金透骨喷雾剂中龙脑的含量及稳定性

目的:建立测定紫金透骨喷雾剂中龙脑含量的方法,并用该方法对制剂中龙脑的稳定性进行考察。方法:采用气相色谱法。色谱柱为AT-WAX石英毛细管柱(0.53mm×30m×1.0μm),检测器为氢火焰离子化检测器(FID),载气为高纯氮气,柱前压为25kPa,柱温为170℃,进样口温度为200℃,检测器温度为250℃,氢气流量为40mL·min-1,空气流量为400mL·min-1。结果:龙脑检测浓度在0.1209～0.7253mg·mL-1范围内与峰面积比值呈良好的线性关系(r=0.9999);平均回收率为99.49%,RSD=2.10%(n=9);制剂中龙脑含量经加速试验和长期试验考察,稳定性良好。结论:本方法简便、快速、准确,可用于紫金透骨喷雾剂的质量控制。

Content Determination and Stability of Borneol in Zijin Tougu Sprays by GC

OBJECTIVE：To establish a method for the content determination of borneol in Zijin tougu sprays,and to study the stability of borneol with this method.METHODS：GC method was adopted.The determination was performed on AT-WAX silica capillary column（0.53 mm ×30 m×1.0 μm）with flame ionization detector（FID）.The carrier gas was high purity nitrogen.The pre-column pressure was 25 kPa,and the column temperature was 170 ℃.The injector temperature was 200 ℃ and the detector temperature was 250℃,respectively.The flow rates of hydrogen and air were 40 mL·min-1 and 400 mL·min-1,respectively.RESULTS：The linear range for borneol was 0.120 9～0.725 3 mg·mL-1（r=0.999 9） with an average recovery of 99.49%（RSD=2.10%,n=9）.The content of borneol in product was found with good stability by accelerated test and long-term test.CONCLUSION：The method is simple,rapid and accurate,and it is suitable for the quality control of Zijin tougu sprays.