HPLC-ELSD法测定依托红霉素片含量的研究

Research of Content Determination for Erythromycin Estolate Tablet by HPLC-ELSD

目的建立以高效液相色谱-蒸发光散射检测器(HPLC-ELSD)法测定依托红霉素片含量的方法。方法大曹三耀(OSAKA SODA GROUP)CAPCELL PAK C_(18) MGⅡS5色谱柱,0.03%二乙胺-乙腈(30∶70,V/V)为流动相,流速为0.9 mL·min^(-1),进样量10μL,柱温40℃。ELSD参数:漂移管温度45℃,载气流速3.3 L·min^(-1),增益为6。结果依托红霉素在0.209~1.257 mg·mL^(-1)的浓度范围内线性关系良好(r=0.9991);精密度、稳定性、重复性试验的RSD<1.5%;加标回收率平均值为99.6%;定量限为0.209μg,检测限为0.067μg。结论该方法操作简单、准确灵敏、稳定性好,可用于依托红霉素片的含量测定。

OBJECTIVE To establish a HPLC-ELSD method for the content determination of erythromycin estolate tablet.METHODS The column was OSAKA SODA GROUP CAPCELL PAK C_(18) MGⅡS5,mobile phase was acetonitrile-0.03%diethylamine(70∶30,V/V),a flow rate of 0.9 mL·min^(-1),the sample size was 10μL,the column temperature was 40℃.ELSD:drift tube temperature was 45℃,carrier gas flow rate was 3.3 L·min^(-1),and the gain was 6.RESULTS The linear range of erythromycin estolate was 0.209-1.257 mg·mL^(-1)(r=0.9991);the RSD of precision,stability and reproducibility tests were no more than 1.5%,the average recovery was 99.6%,limit of quantitation was 0.209μg,the limit of detection was 0.067μg,.CONCLUSION The method is simple to operate and accurate with high sensitivity and stability,and can be used for the content determination of erythromycin estolate tablet.