反相离子对高效液相色谱法测定混悬滴眼液中乙二胺四乙酸二钠含量  

Determination of Edetate Disodium Dihydrate in Loteprednol and Tobramycin Ophthalmic Suspension by RP-HPLC

作　　者：薛琦 杨龙华 

机构地区：[1]山东省青岛市药品检验所,山东青岛266071

出　　处：《中国药业》2012年第1期24-25,共2页China Pharmaceuticals

摘　　要：目的建立反相离子对高效液相色谱法,测定氯替泼诺妥布霉素混悬滴眼液中乙二胺四乙酸二钠(EDTA)的含量。方法色谱柱为Diedma C18柱(150 mm×4.6 mm,5μm);流动相A为氢氧化四丁基铵磷酸盐缓冲液[取10%氢氧化四丁基铵水溶液31 mL,加水390 mL,用磷酸(1→10)溶液调pH至(3.0±0.05),加水至1 600 mL]-乙腈(80∶20),流动相B为乙腈,梯度洗脱;流速为1.0 mL/min;检测波长为280 nm;柱温为30℃。结果 EDTA的质量浓度在0.02～0.10 g/L(r=1.000 0,n=6)范围内与峰面积线性关系良好;平均回收率为100.52%,RSD=0.72%(n=6)。结论该方法快速、灵敏,结果准确可靠,可作为氯替泼诺妥布霉素混悬滴眼液的质量控制项目之一。Objective To develop an RP-HPLC method for the determination of edetate disodium dehydrate（EDTA） in Loteprednol and Tobramycin Ophthalmic Suspension.Methods After being diluted with 0.02%copper sulfate pentahydrate water solution,samples were separated by HPLC on a C18（150 mm×4.6 mm,5 μm） column.The mobile phase A is tetrabutylammonium hydroxide phosphate buffer solution（0.2%tetrabutylammonium hydroxide water solution was adjusted pH to 3.0±0.05 with 10%phosphoric acid water solution）-acetonitrile（80 ∶20）.The mobile phase B is acetonitrile.The mobile phases were gradient eluted.The detection wavelength was 280 nm.The colunm temperature is 30 ℃.Results Calibration curve for EDTA is linear over range of 0.02-0.10 g/L（r=1.000 0,n=6）.And the average recovery is 100.52%,RSD=0.72%（n=6）.Conclution The assay was proved to be sensitive,accurate and convenient with good resolution.It can be applied to control the quality of Loteprednol and Tobramycin Ophthalmic Suspension.

关 键 词：反相离子对高效液相色谱法 乙二胺四乙酸二钠 含量测定 

分 类 号：R927.2[医药卫生—药学] R988.1