气相色谱法拆分醒脑静注射液中龙脑对映体及含量测定

目的: 采用气相色谱法拆分醒脑静注射液中龙脑对映体,并通过对映体的分离测定含量。 方法: 采用CYCLOSIL-B(30 m×0.25 mm×0.25 μm)手性毛细管色谱柱、FID检测器,以内标法测定醒脑静注射液中左旋龙脑和右旋龙脑的含量。 结果: 龙脑对映体在CYCLOSIL-B手性毛细管色谱柱上具有较好的分离效果,其分离度为2.04。左旋龙脑和右旋龙脑线性范围分别为0.048~0.960和0.050~1.008 mg·mL^-1(r≥0.9991);冰片投料为天然冰片的样品中右旋龙脑平均回收率(n=6)为98.4%,RSD为1.8%;冰片投料为艾片的样品中左旋龙脑的平均回收率(n=6)为99.1%,RSD为1.9%。 结论: 所建立的方法简单、准确、可靠,能用于醒脑静注射液的质量控制。

Objective: To develop a GC method to separate and determine the enantiomers of borneol. Methods: The enantiomers of borneol were separated by CYCLOSIL-B chiral capillary chromatographic column(30 m×0.25 mm×0.25 μm)and determined by internal standard method,with FID as detector. Results: The enantiomers of borneol could be baseline separated at CYCLOSIL-B chiral capillary chromatographic column(30 m×0.25 mm×0.25 μm),Resolution of the enantiomers of borneol was 2.04.The calibration curves were linear in the ranges of 0.048-0.960 mg·mL^-1 for(L)-borneol and 0.050-1.008 mg·mL^-1 for(R)-borneol.For sample which came from Borneolum,the average recovery(n=6)of(R)-borneol was 98.4% with RSD of 1.8%,respectively;For sample which came from L-Borneolum,the average recovery(n=6)of(L)-borneol was 99.1% with RSD of 1.9%. Conclusion: This method is simple,rapid and accurate with good reproducibility,and suitable for the quality control of Xingnaojing injection.

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