HPLC法同时测定复方氯霉素滴眼液中醋酸泼尼松龙、氯霉素及其降解产物氯霉素二醇物的含量
发布时间:2018-01-30 07:38
本文关键词: 高效液相色谱法 复方氯霉素滴眼液 氯霉素 醋酸泼尼松龙 氯霉素二醇物 含量测定 出处:《中国药房》2017年03期 论文类型:期刊论文
【摘要】:目的:建立同时测定复方氯霉素滴眼液中氯霉素、醋酸泼尼松龙及其降解产物氯霉素二醇物含量的方法。方法:采用高效液相色谱法。色谱柱为Dionex Acclaim C_(18),流动相为0.1%庚烷磺酸钠溶液-冰乙酸-乙腈-甲醇(60∶0.2∶30∶10,V/V/V/V),流速为1.0 mL/min,检测波长为271 nm,柱温为30℃,进样量为10μL。结果:氯霉素、醋酸泼尼松龙、氯霉素二醇物检测质量浓度线性范围分别为11.73~703.71μg/mL(r=0.999 8)、12.40~744.06μg/mL(r=0.999 8)、1.03~62.03μg/mL(r=0.999 8);氯霉素二醇物的定量限为0.01μg/mL;精密度、稳定性试验的RSD2.0%;氯霉素、醋酸泼尼松龙重复性试验的RSD2.0%,氯霉素二醇物的RSD=4.5%;回收率分别为100.6%~102.7%(RSD=0.60%,n=9)、97.5%~100.3%(RSD=0.80%,n=9)、100.0%~103.2%(RSD=1.10%,n=9)。结论:该方法结果准确、操作简便,可用于复方氯霉素滴眼液中氯霉素、醋酸泼尼松龙及其降解产物氯霉素二醇物含量的同时测定。
[Abstract]:Objective: to establish a simultaneous determination of chloramphenicol in compound chloramphenicol eye drops. Method of determination of chloramphenicol diol in prednisolone acetate and its degradation product. Methods: high performance liquid chromatography was used. The chromatographic column was Dionex Acclaim Che 18). The mobile phase consisted of 0.1% sodium heptane sulfonate solution, glacial acetic acid, acetonitrile-methanol, 60: 0.2: 30: 10 V / V / V / V / V / V / V, the flow rate was 1.0 mL/min. The detection wavelength was 271 nm, the column temperature was 30 鈩,
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