RP-HPLC法测定醋酸氢化可的松滴眼液及注射液的含量  

Determination of content of hydrocortisone acetate eye drops and injections by RP-HPLC methed

作　　者：周建玉[1] 左志辉[1] 左文坚[1] 

机构地区：[1]天津市药品检验所,天津300070

出　　处：《天津药学》2005年第2期31-33,共3页Tianjin Pharmacy

摘　　要：目的:改进醋酸氢化可的松滴眼液和注射液的含量测定方法,为其质量控制提供快速、有效的分析方法。方法:色谱柱为Macherey-nagelC18柱(4.6mm×250mm,5μm),流动相:乙腈-水(38∶62),检测波长254nm,流速:1.0ml/min,柱温:40oC,并进行了方法学验证。结果:醋酸氢化可的松滴眼液和注射液的平均回收率分别为100.6%和99.24%;RSD分别为0.24%(n=6)和0.86%(n=6);醋酸氢化可的松浓度均在4.492～53.904μg/ml范围内,呈良好线性关系(r=0.9999)。结论:该方法快速、简单、准确、灵敏、重现性好,能更好地控制该药品质量。0bject:To establish an HPLC method for determination of content of hydrocortisone acetate eye drops and injections by RP-HPLC and provide a rapid and effectual method for their quality control. Methods: A Macherey-Nagel C_(18) (4.6 mm×250 mm,5μm)column was used .The mobile phase consisted of acetonitrile and water (38∶62,v/v). The flow rate was 1.0 ml/min, UV detection was set at 254 nm and the column temperature was 40(C. The method validation was performed. Results: The average recoveries were 100.6% with RSD% of 0.24% for hydrocortisone acetate eye drops ((n=)6) and 99.24% with RSD% of 0.86% for hydrocortisone acetate injection (n=6), respectively. The linear range of hydrocortisone acetate was 4.492～53.904 μg/mL (r=0.9999). Conclusion: This method was rapid, simple, accurate and sensitive, which can be used for better control of the quality of hydrocortisone acetate eye drops and injection.

关 键 词：高效液相色谱法 醋酸氢化可的松滴眼液及注射液 含量测定 

分 类 号：R972.2[医药卫生—药品]