气相色谱法测定盐酸加替沙星中的残留溶剂

目的：建立测定盐酸加替沙星中7种有机溶剂的分离测定方法。方法：用Agilent DB-624毛细管气相色谱柱和氢火焰离子化检测器,按顶空进样方式同时测定了盐酸加替沙星中甲醇、乙腈、乙醇、醋酸乙酯、二氯甲烷、环己烷、甲苯的残留量。结果：各有机溶剂均能得到有效分离,在所考查的浓度范围内线性关系良好,平均加样回收率（n=9）为91.0%~103.0%（RSD为0.9%~6.4%）（r=0.993 6~0.999 9）。结论：该检测方法简单、可靠,可以用于盐酸加替沙星原料药的质量控制。

Determination of residual solvent in gatifloxacin hydrochloride by gas chromatography

Objective： To establish a method for determining seven residual solvents in gatifloxacin hydrochlorid. Methods： A trace of methanol,acetonitrile,ethanol,ethyl acetate,dichloromethane,cyclohexane and toluene was determined in a way of headspace sample injection by a gas chromatography with DB- 624 capillary column（ 30 m × 0. 53 mm,3 μm） and an FID detector. Results： All the residul solvents were completely separated and a good linearity existed within the range of analytical concentrations（ r = 0. 993 6 ~ 0. 999 9） for all the solvents. The average recovery lay between 91. 0% ~ 103. 0%（ RSD was 0. 9% ~6. 4%）. Conclusions： The method developed here is simple,accurate and available for quality control for gatiflo- xacin hydrochloride.