反相高效液相色谱法测定双氯芬酸钠栓剂的含量  

Content determination of diclofenac sodium suppositories by RP-HPLC

作　　者：刘腊娥 戴莙 陈非凡 

机构地区：[1]解放军第163中心医院药剂科,长沙410003

出　　处：《中南药学》2008年第1期48-50,共3页Central South Pharmacy

摘　　要：目的 建立双氯芬酸钠栓剂含量测定方法。方法 采用反相高效液相色谱法测定该制剂中双氯芬酸钠的含量，色谱柱为Symnetry-C18柱（250mm×4．6mm，5μm），流动相为甲醇-水-36％醋酸（82：17：1.0），检测波长279nm，流速为1．0mL·min^-1，柱温25℃。结果双氯芬酸钠浓度在8～40μg·mL^-1。内线性关系良好（r＝0．9991），平均回收率为97．13％，RSD为1．1％（n＝6）。结论该法结果准确，重复性好，为该栓剂制订质量标准提供了科学的方法学参考。Objective To establish an RP-HPLC （reversed phase high performance liquid chromatography） method for the determination of content in diclofenac sodium suppositories. Methods Content of diclofenac sodium suppositories were determined by RP-HPLC. Symmetry-C18 column （250 mm×4.6 mm, 5 μm） was used as chromatography column, while methanol ： water ： 36% acetic acid （82 ： 17 ： 1.0） was used as the mobile phase, and the detective wavelength was 279 nm. The flow rate was 1.0 mL ~ min-1 , and the column temperature was 25 ℃. Results The linear range of dielofenae sodium was 8～40 μg · mL^-1 （r=0. 999 9）, the average recovery was 97. 13%and RSD was 1.1% （n=6）. Conclusion This method is accurate with good reproducibility, and can provide scientific refer- enee for establishing the quality criteria of dielofenae sodium suppositories.

关 键 词：双氯芬酸钠 高效液相色谱法 栓剂 含量 

分 类 号：R917[医药卫生—药物分析学]