HPLC法测定维A酸与异维A酸含量  

HPLC determination of tretinoin and isotretinoin

作　　者：王福霞[1] 冯文菊 姜武民 

机构地区：[1]湖北宜昌市第一人民医院,宜昌443000 [2]湖北恒安药业股份有限公司,宜昌443000

出　　处：《药物分析杂志》2007年第4期585-587,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立HPLC法测定维A酸和异维A酸的含量方法。方法:采用Kromasil C_(18)(4.6mm×250mm,5μm)色谱柱,以甲醇-水-冰醋酸(90∶10∶0.5)为流动相,流速为1.0mL·min^(-1),柱温为30℃,检测波长为358nm。进样量20μL。结果:维A酸在4.4～17.4μg·mL^(-1)范围内线性关系良好,回归方程为A=8.127×10~3C+8.5698×10~2(r=0.9997),平均回收率为99.1%(RSD=0.7%)。异维A酸在1.083～4.332μg·mL^(-1)范围内线性关系良好,回归方程为A=103.73C+2.4(r=0.9999),平均回收率为100.1%(RSD=0.6%)。结论:该方法快速、准确,灵敏度高,重复性好,而且与其他降解产物能较好的分离。Objective：To establish an HPLC method for the determination of tretinoin and isotretinoin. Methods： The column was Kromasil C18 （4.6 mm ×250mm,5μm） ,the mobile phase consisted of methanol - water - glacial acetic acid（90： 10： 0. 5 ）, the flow rate was 1.0 mL · min^-1, the detection wavelength was 358 nm, the column temperature was 30 ℃. Results： Tretinoin ： The calibration curve was linear in the range of 4.4 - 17.4 μg·mL^-1 with r = 0. 9997, and the regression equation was A = 8. 127 ×10^3 C ＋ 2.4 （ r = 0. 9997 ） ; Isotretinoin ： The calibration curve was linear in the range of 1. 083 -4. 332 μg · mL^-1 with r = 0. 9999, and the regression equation was A = 103.73 C ＋ 2. 4 （ r = 0. 9999 ）. The average recovery was 100. 1% （ RSD = 0. 6% ）. Conclusion： The method is rapid,accurate, sensitive and reproducible for quality control of tretinoin and isotretinoin and can be separated to its degradation products.

关 键 词：高效液相色谱 维A酸 异维A酸 含量 

分 类 号：R917[医药卫生—药物分析学]