高效液相色谱法测定双唑泰凝胶中抑菌剂羟苯乙酯

Determination of ethylparaben in Shuangzuotai gel by high performance liquid chromatography

建立高效液相色谱法测定双唑泰凝胶中抑菌剂羟苯乙酯含量的分析方法。以Agilent Zorbax SB C8柱(250 mm×4.6 mm,5μm)为分析柱,流动相为甲醇-水-三乙胺(体积比为70∶30∶0.3,含10 mmol/L的庚烷磺酸钠,用磷酸调pH至4.0),流量为1.0 mL/min,检测波长为256 nm,柱温为30℃,进样体积为20μL。羟苯乙酯的质量浓度在0.5128~51.28μg/mL范围内与色谱峰面积线性关系良好,相关系数为0.9999,方法检出限为0.08μg/mL。样品测定结果的相对标准偏差为0.3%(n=6),平均加标回收率为100.9%。该方法简便可行,准确可靠,灵敏度高,重现性好,可用于双唑泰凝胶中羟苯乙酯的含量测定,以便对双唑泰凝胶质量指标进行全面评价。

The method was established for the determination of ethylparaben in Shuangzuotai gel by high performance liquid chromatography.Agilent Zorbax SB C8 column(250 mm×4.6 mm,5μm)was used as analysis column,methyl alcohol-water-triethylamine solution(volume ratio was 70∶30∶0.3,containing 10 mmol/L sodium heptanesulfonate,pH was adjusted to 4.0 by phosphoric acid)was used as the mobile phase with the flow rate of 1.0 mL/min,the detection wavelength was 256 nm,the column temperature was 30℃,and the injection volume was 20μL.The chromatograph peak area of ethylparaben had a good linear relation with the mass concentration in the range of 0.5128-51.28μg/mL with the correlation coefficient of 0.9999,and the detection limit of the method was 0.08μg/mL.The relative standard deviation of the determination results was 0.3%(n=6),and the average standard addition recovery was 100.9%.The method is simple,accurate,sensitive and reproducible,which can be used for the determination of ethylparaben in Shuangzuotai gel,so as to comprehensively evaluate the quality index of Shuangzuotai gel.