高效液相色谱法测定注射用复方粉针剂中地塞米松磷酸钠和去甲万古霉素的含量  

Determination of dexamethasone phosphate sodium and norvancomycin hydrochloride for in compound injection by HPLC

作　　者：李云兰[1] 刘芳[1] 李青山[1] 赵敬华[1] 

机构地区：[1]山西医科大学药学院,山西太原030001

出　　处：《中国现代应用药学》2004年第4期314-316,共3页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的　建立高效液相色谱法同时测定复方粉针剂中地塞米松磷酸钠和去甲万古霉素的含量。方法　采用SphereSorbC18色谱柱 (4 .6mm× 2 5 0mm ,10 μm) ,甲醇 0 .0 1mol·L-1磷酸氢二铵 (2 0∶80 ,磷酸调 pH6 .0 )为流动相 ,检测波长 :2 14nm ,流速 :1.0mL/min ,柱温为 30℃ ,进样量 2 0 μL。 结果　地塞米松磷酸钠线性范围为 9.6～ 4 8mg·L-1,回归方程Y =30 6 0 5 .3X +16 315 .8,r=0 .9999,平均回收率 98.1% ,RSD为 0 .92 % (n =9) ;去甲万古霉素线性范围 2 0～ 10 0mg·L-1,回归方程Y =5 171.6X - 84 35 .4 ,r=0 .9993,平均回收率 10 0 .5 % ,RSD为 1.0 % (n =9)。结论　方法简便、可靠、结果准确 。OBJECTIVE To establish a method for determination of dexamethasone phosphate sodium and norvancomycin hydrochloride in compound injection with HPLC. METHOD A column of Spheresorb C 18 was used. The mobile phase consisted of methanol-0.01mol/L(NH 4)H 2PO 4 (20∶80, adjust to pH6.0 with H 3PO 4) and the flow rate was 1.0mL/min. The UV detection wavelength was 214nm. Columm temperature was 30℃.RESULTS The standard curve of dexamethasone phosphate sodium was linear over the range of 9.6～48mg·L -1. The calibration curve was Y=30605.6X+16315.8, r=0.9999. The average recovery was 98.1% with RSD 0.92%(n=9). The standard curve of norvancomycin hydrochloride was linear in the range of 20～100mg·L -1. The calibration curve was Y=5171.6X-8435.4,r=0.9993. The average recovery was 100.5% with RSD 1.0%(n=9).CONCLUSION The method is simple and accurate. It can be used for quality control of this preparation.

关 键 词：高效液相色谱法 地塞米松磷酸钠 去甲万古霉素 

分 类 号：R917.01[医药卫生—药物分析学] R988.1[医药卫生—药学]