高效液相色谱法测定盐酸金霉素眼膏中有关物质  

Determination of related substances in Chlortetracycline hydrochloride eye ointment by HPLC

作　　者：刘钐[1] 高丹玲[1] 

机构地区：[1]福建省药品检验所,福州350001

出　　处：《海峡药学》2013年第1期51-54,共4页Strait Pharmaceutical Journal

摘　　要：目的建立HPLC法测定盐酸金霉素眼膏中有关物质。方法色谱柱为C8柱（250×4．6mm，5um）；柱温：45℃；流动相为高氯醢．二甲亚砜-水（8：525：467）；检测波长为280hm。结果该方法盐酸四环素在O．016rag·mL-1～0．160mg·mL-1的范围内具有良好的线性，直线回归方程为A=4．0×10^7C-6．9367×10^3，相关系数r=0．99995，平均回收率为101．3％，RSD为1．1％。4．差向金霉素在0．0080mg·mL-1～0．0803mg·mL-1的范围内具有良好的线性，直线回归方程为A=3．0×10^7C-1．029×10^4，相关系数r=0．99995，平均回收率为97．3％，RSD为2．5％。结论该法简便、可靠、准确，可作为盐酸金霉素有关物质的方法。OBJECTIVE To establish a HPLC method for the determination of related substances in Chlorte-tracycline Hydrochloride Ointment. METHODS Cs column was used; the column temperature was maintained at 45℃ ;mobile phase consisted of water-Dimethyl Sufoxid-Perchloric Acid（467：525 ： 8）;and detecting wavelength Was at 280nm. RESULTS This method had good Linearity range of Tetracycline Hydrochloride within 0.1mg.mL-1-2mg.mL- 1 regression equation A = 4.0 × 10^7C - 6. 9367×10^3, Relative coefficient r = 0. 99995, The av- erage Recovery rate was 101.3 %. This method had good Linearity range of 4-epichlortetraeycline Hydrochloride within 0. 1mg. mL-1 2mg.mL-1 regression equation A = 3.0×10^7C- 1. 029 ×10^4, Relative coefficient r = 0. 99995, The average Recovery rate was 97.3 %. CONCLUSION The method is simple, reliable and accurate for related substances of Chlortetracycline Hydrochloride Eye Ointment.

关 键 词：盐酸四环素 4-差向金霉素 盐酸金霉素眼膏 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学]