高效液相法同时测定复方二氯醋酸二异丙胺注射液两组分的含量

目的建立了用HPLC测定复方二氯醋酸二异丙胺注射浪中二氯醋酸二异丙胺和葡萄糖酸钠两种组分的含量。方法色谱柱为GracesmartRP18柱（4．6mm×250mm，5μm），流动相为缓冲液（磷酸二氢钠15．6g，加水900mL使溶解，加乙腈100mL，加10％四丁基氢氧化铵50mL，混匀，用稀磷酸或1mol·L^-1氢氧化钠溶液调节pH值至6．5，加四氢呋喃65mL），流速为1．0mL·min^-1，检测波长为205nm。结果二氯醋酸二异丙胺和葡萄糖酸钠的线性范围分别为20～60μg·mL^-1（r=0．9999）和19～57μg·mL^-1（r=0．9999），平均回收率和RSD分别为100．6％。0．37％和101．4％，0．90％。结论该方法简便、准确、快速，能消除干扰，可用于测定复方二氯醋酸二异丙胺注射液中二氯醋酸二异丙胺和葡萄糖酸钠的含量。

Determination of two component in Compound diisopropylamine dichloroacetate injection by HPLC

OBJECTIVE To establish an HPLC method for the determination of diisopropylamine dichloroacetate and sodium gluconate in compound diisopropylamine dichloroacetate injection. METHODS The analytical column was Gracesmart RP18 column （4.6mm × 250mm, 5μm）and the mobile phase was buffer （NaH2PO4 15.6g, adds water 900mL to cause the dissolution and acetonitrile 100mL, 10 % tetrabutyl ammonium hydroxide 50mL, mixing with diluted phosphoric acid, or 1mol·L^-1 sodium hydroxide solution adjusting the pH value to 6.5, and tetrahydrofuran 650mL） at a flow rate of 1.0mL·min^-1. Detected at 205nm by UV-detector. RESULTS Their linear ranges were 20-- 60 μg·mL^-1 （r = 0. 9999） and 19 -- 57μg·mL^-1 （r = 0. 9999）, respectively. The average recoveries of the two components were 100.6 % with RSD 0.37 %, and 101.4 % with 0.90 %, respectively. CONCLUSION The results show that the method was simple, precise and rapid, and it also can eliminate interference. It was suitable for the determination of diisopropylamine dichloroacetate and sodium glueonate in compound diisopropylamine dichloroacetate injection.