高效液相色谱法测定复方醋酸曲安奈德溶液中2种抗氧剂含量

Content Determination of Two Antioxidants in Compound Triamcinolone Acetonide Acetate Solution by HPLC

目的建立测定复方醋酸曲安奈德溶液中3-叔丁基-4-羟基苯甲醚(BHA)和2,6-二叔丁基对甲酚(BHT)含量的高效液相色谱法。方法色谱柱为Merck RP-18 Endcapped柱(250 mm×4.6 mm,5μm),流动相为甲醇-水(梯度洗脱),流速为1.0 mL/min,检测波长为280 nm,柱温为30℃,进样量为10μL。结果BHA和BHT质量浓度均在0.04~0.20 g/L(r>0.9990)范围内与峰面积线性关系良好;BHA和BHT定量限分别为0.2μg/mL和0.4μg/mL,检出限分别为0.04μg/mL和0.10μg/mL;精密度、稳定性、重复性试验的RSD均小于1%;平均加样回收率分别为98.22%和99.35%,RSD分别为0.64%和1.12%(n=9)。结论该方法精密度、稳定性、重复性均较好,可用于测定复方醋酸曲安奈德溶液中BHA和BHT的含量。

Objective To establish an HPLC method for the content determination of 3-tert-butyl-4-hydroxyanisole(BHA)and 2,6-di-tert-butyl-4-methylphenol(BHT)in Compound Triamcinolone Acetonide Acetate Solution.Methods The chromatographic column was Merck RP-18 Endcapped column(250 mm×4.6 mm,5μm),the mobile phase was methanol-water(gradient elution),the flow rate was 1.0 mL/min,the detection wavelength was 280 nm,the column temperature was 30℃and the sample size was 10μL.Results BHA and BHT showed good linear relationship with the peak area in the range of 0.04-0.20 g/L(r>0.9990).The limits of quantitation of BHA and BHT were 0.2μg/mL and 0.4μg/mL,respectively,and the detection limits of BHA and BHT were 0.04μg/mL and 0.10μg/mL,respectively.The RSDs of accuracy,stability and repeatability tests were all less than 1%.The average recoveries of BHA and BHT were 98.22%and 99.35%,RSDs were 0.64%and 1.12%(n=9),respectively.Conclusion The method has good precision,stability and repeatability,which can be used for the content determination of BHA and BHT in Compound Triamcinolone Acetonide Acetate Solution.