高效液相色谱法检测环索奈德鼻喷雾剂的防腐剂  

Determination of Preservatives in Ciclesonide Nasal Spray by HPLC

作　　者：沈丹丹 许娟 姜学美 肖波 SHEN Dandan;XU Juan;JIANG Xuemei;XIAO Bo(Chongqing Institute for Food and Drug Control,Chongqing,China 401121;Chongqing Research Center for Drug Process and Quality Control Engineering,Chongqing,China 401121;Chongqing Rennzar Pharmaceutical Technology Co.,Ltd.,Chongqing,China 400021)

机构地区：[1]重庆市食品药品检验检测研究院,重庆401121 [2]重庆市药物过程与质量控制工程技术研究中心,重庆401121 [3]重庆仁泽医药科技有限公司,重庆400021

出　　处：《中国药业》2019年第9期46-49,共4页China Pharmaceuticals

摘　　要：目的建立同时测定环索奈德鼻喷雾剂中防腐剂山梨酸钾和依地酸二钠含量的高效液相色谱(HPLC)法。方法色谱柱为InertsilODS-3 C18柱(250 mm×4. 6 mm,5μm),流动相为乙腈-0. 02 mol/L硼砂溶液(10∶90),流速为1. 0 m L/min,检测波长为288 nm,柱温为30℃。结果依地酸二钠和山梨酸钾色谱峰之间的分离度大于1. 5,依地酸二钠及山梨酸钾质量浓度分别在3. 209 6～12. 838 4μg/m L(r=0. 999 9),38. 46～153. 82μg/m L(r=0. 999 8)范围内与峰面积线性关系良好,平均回收率分别为99. 84%和96. 96%,RSD分别为0. 96%和2. 17%(n=9);山梨酸钾在光照条件下含量下降。结论该方法可用于环索奈德鼻喷雾剂中防腐剂的质量控制。Objective To establish an HPLC method for simultaneous determination of potassium sorbate and disodium edetate in Ciclesonide Nasal Spray.Methods The chromatographic column was Inertsil^■ODS-3 C18 column(250 mm×4.6 mm,5μm),the mobile phase was acetonitrile-0.02 mol/L borax solution(10∶90),the flow rate was 1.0 mL/min,the detection wavelength was 288 nm,and the column temperature was 30℃.Results The separation degree between the chromatographic peaks of disodium edetate and potassium sorbate was more than 1.5.Disodium edetate and potassium sorbate showed good relationship in the ranges of 3.209 6-12.838 4μg/mL(r=0.999 9),38.46-153.82μg/mL(r=0.999 8).The average recovery rates of disodium edetate and potassium sorbate were 99.84%and 96.96%,RSDs were 0.96%and 2.17%(n=9).The experimental results of influencing factors showed that the content of potassium sorbate decreased under illumination test.Conclusion The method can be used for the quality control of preservatives in Cyclosonide Nasal Spray.

关 键 词：环索奈德鼻喷雾剂 依地酸二钠 山梨酸钾 防腐剂 高效液相色谱 影响因素 质量控制 

分 类 号：R927.11[医药卫生—药学] R987