HPLC法同时测定四环素可的松眼膏中四环素和醋酸可的松的含量

Simultaneous determination of tetracycline and cortisone acetate in its compound eye ointment by HPLC method

目的:建立一种同时测定四环素可的松服膏中四环素和醋酸可的松含量的HPLC法。方法:采用依利特HYPERSILBDS-C_(18)(300mm×4.0mm,5μm)为色谱柱,0.01mol·mL^(-1)十二烷基硫酸钠溶液(用磷酸调节pH值至2.5)-乙腈(60:40,V/V)为流动相,检测波长254nm,流速0.8mL·min^(-1),柱温40℃。结果:四环素在9.99～249.80μg·mL^(-1)浓度范围内有良好的线性关系(r-1.0000),回收率为(102.39±0.72)％(RSD=0.71％,n=9),最低定量限为13.0ng;醋酸可的松在10.20～255.00μg·mL^(-1)浓度范围内有良好的线性关系(r=1.0000),回收率为(99.59±1.59)％(RSD=1.60％,n=9),最低定量限为7.1ng。结论:本方法简便,灵敏,准确,适合于四环素可的松眼膏的质量控制。

AIM: To establish an HPLC method for simultaneous determination of tetracycline and cortisone acetate in its compound eye ointment. METHODS: A HYPERSIL BDS-C18 column (300 mm x 4.0 mm, 5 pan) was adopted as stationary phase, 0.01 mol mL-1 sodium lauryl sulfate solution (adjustment of pH to 2.5 with phosphoric acid)-acetonitrile (60:40, V/V) was used as mobile phase, the detection wavelength was 254 nm, the flow rate was 0.8 mL'min~', and the temperature of column was 40 C . RESULTS: Tetracycline had a good linearity (r= 1.000 0) in the range of 9.99-249.80 g mL-1, the average recovery was (102.39 + 0.72) % (RSD = 0.71%, ra = 9) , and the limit of detection was 13.0 ng. Cortisone acetate had a good linearity (r=1.000 0)in the range of 10.20-255.00 ug mL-1, the average recovery was (99.59 + 1.59) % (RSD=1.60% , n=9) , and the limit of detection was 7.1 ng. CONCLUSION: The method is simple, sensitive and accurate, and can be used for the quality control of compound tetracycline and cortisone eye ointment.