摘要
目的:建立顶空气相色谱检测奥昔布宁透皮贴剂中乙酸乙酯及环己烷的方法。方法:采用顶空程序升温气相色谱法,顶空平衡温度100℃,平衡时间25.0min,色谱柱为 DB-624(30m×0.53mm×3μm),柱温初始为60℃,保持8min,然后以60℃·mim^(-1)的速率升温到250℃,保持10min。结果:乙酸乙酯在0.21～2.20mg·g^(-1)浓度范围内线性关系良好,相关系数0.999,回收率98.2%,最低检测限为1μg;环己烷在0.15～1.23mg·g^(-1)浓度范围内线性关系良好,相关系数0.999,回收率98.5%,最低检测限为1μg。结论:本法快速、可行,检测结果较为满意。
Objective：To establish a headspace - GC method for the analysis of ethyl acetate and cyclohexane in Oxybutynin Transdermal Drug Deliver System（ TDDS）. Method：Use headspace GC, the equilibration temperature of headspace is 100 ℃ and the equilibration time is 25.0 min. Use DB -624 （30 m × 0. 53 mm × 3 μm）as column and keep oven temperature at 60 ℃ for 8 min, then increase the temperature to 250 ℃ at the rate 60 ℃ · mim^-1, finally keep the temperature for 10 min. Result：The linear correlation of ethyl acetate in TDDS is observed from the concentrations of 0. 21 - 2. 20 mg · g ^-1 （ r = 0. 9999 ）. The linear correlation of cyclohexane in TDDS is observed from the concentrations of 0. 15 -1.23 mg · g^-1 （r =0. 9999）. The recoveries of ethyl acetate and cyclohexane are 98. 2% and 98.5% respectively. The LOD both are 1 μg. Conclusion：The method is fastness and convenience.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2005年第11期1296-1298,共3页
Chinese Journal of Pharmaceutical Analysis
