HPLC法测定复方地塞米松滴耳液中二组分的含量

Determination of two components in compound dexamethasone eardrops by RP-HPLC

目的建立HPLC法测定复方地塞米松滴耳液中二组分的含量。方法采用Waters XTerraRP18(250mm×4.6mm,5μm),以甲醇-水(70∶30)为流动相,流量为1.0mL.min-1,柱温为30℃,检测波长240nm。结果本色谱条件下醋酸地塞米松和氯霉素分离良好。醋酸地塞米松、氯霉素分别在0.002～0.05mg.mL-1和0.02～0.5mg.mL-1浓度范围内,与峰面积呈良好的相关性(r=1.0000和r=0.9999);平均回收率:醋酸地塞米松为100.3%,RSD为0.7%(n=9),氯霉素为100.0%,RSD为0.4%(n=9)。结论该方法简便、准确、可靠,适用于复方地塞米松滴耳液的定量检测。

OBJECTIVE To establish a method for the determination of two components in compound dexamethasone eardrops by RP-HPLC.METHODS A waters XTerraRP18 column was used.The mobile phase was methanol-water（70∶30）.The flow rate was 1.0 mL·min-1.The column temperature was 30℃.The UV detection wavelength was 240 nm.RESULTS Complete separation was achieved among two compounds under optimun conditions.Dexamethasone acetate and Chloramphenicol was respectively liner in the range from 0.002mg·mL-1 to 0.05mg·mL-1（r=1.0000）,0.02mg·mL-1 to 0.5mg·mL-1（r=0.9999）.The average recovey of dexamethasone acetate was 100.3%（RSD=0.7%）,Chloramphenicol was 100.0%（RSD=0.4%）.CONCLUSION The method is simple,accurate,reliable and suitable for the determination of compound dexamethasone eardrops by RP-HPLC.