HPLC法同时测定复方地克软膏中3组分的含量

摘要

OBJECTIVE:To establish a method for the simultaneous determination of chloramphenicol,clotrimazole and dexa-methasone acetate in compound dike ointment. METHODS:HPLC was performed on the column of Thermo BDS Hypersil C18 with methanol-0.05 mol/L potassium dihydrogen phosphate(pH=5.7)(gradient elution) at flow rate of 1.0 ml/min,detection wave-length was 235 nm,column temperature was 35℃and volume injection was 10μl. RESULTS:The linear range was 0.10-0.40 mg/ml for chloramphenicol,0.05-0.20 mg/ml for clotrimazole and 0.03-0.12 mg/ml for dexamethasone acetate;RSDs of precision,sta-bility and reproducibility tests were lower than 2%;recoveries were 95.42%-103.28%(RSD=2.8%,n=9),97.12%-102.96%(RSD=1.8%,n=9)and 95.10%-102.69%(RSD=2.9%,n=9),respectively. CONCLUSIONS:The method is simple,rapid,ac-curate and reproducible,and suitable for the quality control of compound dike ointment and other related preparation.%目的：建立同时测定复方地克软膏中氯霉素、克霉唑和醋酸地塞米松含量的方法。方法：采用高效液相色谱法。色谱柱为Thermo Hypersil BDS C18，流动相为甲醇-0.05 mol/L磷酸二氢钾（pH＝5.7）（梯度洗脱），流速为1.0 ml/min，检测波长为235 nm，柱温为35℃，进样量为10μl。结果：氯霉素、克霉唑、醋酸地塞米松检测质量浓度分别在0.10～0.40、0.05～0.20、0.03～0.12 mg/ml范围内与峰面积呈良好的线性关系；精密度、稳定性、重复性试验的RSD＜2％；回收率分别为95.42％～103.28％、97.12％～102.96％、95.10％～102.69％，RSD分别为2.8％、1.8％、2.9％（n＝9）。结论：该方法简便快速、结果准确、重复性好，适用于复方地克软膏及相关制剂的质量控制。