高效液相色谱法测定环孢素眼用乳状液的含量Content Determination of Ciclosporin Ophthalmic Emulsion by HPLC
王延东,唐细兰,叶成添,黄楚龙
WANG Yan-dong,TANG Xi-lan,YE Cheng-tian,HUANG Chu-long(Zhongshan Ophthalmic Center
摘要(Abstract)：
目的建立测定环孢素眼用乳状液含量的高效液相色谱法。方法采用Eclipse XDB-C8柱(4.6mm×150mm,5μm)为色谱柱;流动相为乙腈-甲醇-水(67.5∶5∶27.5);流速为0.8ml/min;检测波长为210nm;柱温为55℃。结果环孢素在5～60mg/L浓度范围内线性关系良好(r=0.9999),平均回收率为100.4%,相对标准偏差值RSD为1.15%,方法重现性的(RSD)为0.29%(n=6)。结论该方法简便、快速、灵敏,可以有效控制产品的质量。
Objective To establish a HPLC method for the content determination of ciclosporin ophthalmic emulsion. Methods The separation was performed on Eclipse XDB-C8 (4.6 mm×150 mm,5 μm),the mobile phase was acetonitrile-methanol-water (67.5∶5∶27.5)with the flow rate of 0.8 ml/min. The detection wavelength was at 210 nm,and column temperature was 55℃. Results The calibration curve of ciclosporin was linear within the concentration range of 5~60 mg/L,r=0.9999. The average recovery of ciclosporin was 100.4% (RSD=1.15%),the RSD of the repeatability test was 0.29%(n=6).Conclusion The method is simple,rapid,and accurate. It can be effectively used to control the quality of product.
关键词(KeyWords)：
高效液相色谱法;环孢素;眼用乳状液
HPLC; ciclosporin; ophthalmic emulsion
基金项目(Foundation): 广东省医院药学研究基金资助项目(编号:2009B008)
作者(Author):
王延东,唐细兰,叶成添,黄楚龙
WANG Yan-dong,TANG Xi-lan,YE Cheng-tian,HUANG Chu-long(Zhongshan Ophthalmic Center
参考文献(References)：
- 1Abelson MB,Walker P,Ousler GW.Dry Eye Diagnosis:It's All a Blur.Reviewof Ophthalmol,2006,13(12):50-52.
- 2Barabino S,Dana MR.Dry eye syndromes.Chem Immunol Allergy,2007,92:176-184.
- 3Pflugfelder SC.Anti-inflammatory Therapy of Dry Eye.Ocul Surf,2003,1(1):31-36.
- 4Wilson,SE,Perry HD.Long-term Resolution of Chronic Dry Eye Symptoms and Signs after Topical Cyclosporine Treatment.Ophthalmol,2007,114(1):76-79.
- 5Perry HD,Donnenfeld ED.Topical0.05%cyclosporin in the treatment of dry eye.Expert Opin Pharmaco ther,2004,5(10),2099-2107.
- 6国家药典委员会.中国药典.第二部.北京:化学工业出版社,2005.306.