眼用制剂中清凉剂的气相色谱测定方法

目的 用气相色谱法同时检测眼用制剂中各种清凉剂含量.方法 色谱条件:OV-1701石英毛细管柱；选样口温度:220℃；炉温:105℃；FID检测器温度:250℃；载气:氮气,6.0 psi;氢气:45 mL/min；空气:450 mL/min；分流比:10∶1；以乙酸乙酯萃取样本,正十三烷为内标.结果 樟脑、异龙脑、薄荷醇、龙脑分离良好,在浓度2.0～250.0 μg·mL-1间与内标峰面积之比线性良好,方法学考察结果符合要求.结论 该方法定量准确,可用于眼用制剂中清凉剂辅料的研究.

Determination of Algefacient in Ophthalmic Preparation by Gas Chromatography

Objective To establish a gas chromatography(GC) method for simultaneous determination of algefacients in ophthalmic preparation.Methods The chromatographic procedure was carried out in OV-1701 capillary column.The chromatographic conditions were as follows:injection temperature at 220 ℃,oven temperature at 105 ℃,FID detector temperature at 250 ℃,carrier gas being nitrogen 6.0 psi,hydrogen flow rate at 45mL/min,air flow rate at 450 mL/min,and split ratio being 10 ∶ 1.Samples were extracted by ethyl acetate,and tridecane was used as the internal standard substance.Results Camphor,isoborneol,menthol and borneol were separated from other components of ophthalmic preparation,and they had good linearity in the rang of 2.0～250.0 μg·mL-1.All items of empirical method conformed to requirements.Conclusion The established method is precise and effective,and can be used for qualitation and quantitation of algefacient components in ophthalmic preparation.