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作 者:刘刚[1] 张捷[1,2] 兰青[1] 谭生建[1] 王杰松[1] 迟家平[1]
机构地区:[1]解放军306医院,北京100101 [2]解放军医学院,北京100853
出 处:《解放军药学学报》2014年第5期439-441,共3页Pharmaceutical Journal of Chinese People's Liberation Army
基 金:军队医疗机构制剂标准提高专项课题;No.13ZJZ01-1
摘 要:目的用HPLC法验证原有测定枸橼酸钾溶液中枸橼酸钾和羟苯乙酯含量的方法,并与原方法进行比对。方法采用Nucleodur C18Pyramid(250 mm×4.6 mm,5μm)色谱柱。梯度洗脱,流动相A:水-磷酸(1000∶1);流动相B:乙腈。洗脱程序:0~5 min,A100%;5.01~22 min:A70%,B30%;22.1~30 min,A100%;流速1 ml·min^-1,检测波长210 nm。结果以峰面积(Y)对进样浓度(X,μg·ml^-1)进行线性回归,枸橼酸钾回归方程为Y=2.586 X-16.49,r=0.9999,线性范围500.8~5008μg·ml^-1;羟苯乙酯回归方程为Y=0.021 44 X-0.4065,r=0.9999,线性范围2.503~25.03μg·ml^-1;枸橼酸钾回收率为100.2%,RSD为0.15%;羟苯乙酯回收率为99.6%,RSD为1.9%。结论 HPLC法测定结果准确,重复性好,操作简便,优于原方法,可更好的用于枸橼酸钾溶液中枸橼酸钾和羟苯乙酯的含量测定。Objective To develop an HPLC quantitative method for the determination of potassium citrate and ethylparaben and contrast it with the original method in potassium citrate solution. Methods The chromatograph- ic conditions included column C18 (250 mm×4.6 mm,5μm) , mobile phase A: water-phosphoric acid( 1000:1 ) , mobile phase B : acetonitrile, gradient elution : 0 - 5 min, A : 100 % , 5.01 - 22 min, A70% , B : 30%, 22.10 - 30 min, A100%. The flow rate was 1 ml .min^-1 and monitored at 210 nm. Results The regress equation for potassium citrate was Y =2. 586 X - 16.49, r =0. 9999 ,and the linear range was 500.8 -5008μg .ml^-1. The average recovery of potassium citrate was 100.2%, RSD = 0. 15%. The regress equation for ethylparaben was Y = 0. 021 44 X - 0. 4065, r = 0. 9999, and the linear range was 2. 503 - 25.03 μg .ml^-1. The average recovery of ethylparaben was 99.6 % , RSD = 1.9%. Conclusion HPLC method is accurate, simple, time-saving and better than the original one. It can be used for routine analysis of potassium citrate and ethylparaben in potassium citrate solution.
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