中国执业药师2016，Vol.13Issue(4)：11-15,17,6.DOI:10.3969/j.issn.1672-5433.2016.04.003
环孢素软胶囊溶出度HPLC检测方法改进研究
Improvement of HPLC Method for Determination of Dissolution of Ciclospor in Soft Capsules
刘虹 1赵海鹏 1李源 1陈燕1
作者信息
- 1. 潍坊市食品药品检验检测中心，山东 潍坊 261205
- 折叠
摘要
Abstract
Objective:To improve the HPLC method for determination of dissolution of ciclosporin soft cap-sules.Methods:The paddle method was adopted using 0.5% sodium dodecyl sulfonate containing 0.1 mol/L HCl as a media at a rotation rate of 75 rpm. Samples were taken from the products of manufacturers at time points (15,30,45,60,75 and 90 min)and determined for dissolution,based on which a dissolution curve was plot-ted. HPLC was performed with C8(2)column(4.6 mm×250 mm,5μm)at a column temperature of 60 ℃, using the mixture of 0.1% trifluoroacetic acid,tetrahydrofuran,acetonitrile and 0.5% triethylamine(20∶25∶40∶15, adjusted to pH 2.4 using phosphoric acid)as mobile phase at a flow rate of 1.0 mL/min. The wavelength for de-tection was 210 nm.Results:The linear range of the method was 5 ~100μg/mL,while the quantitation and de-tection limits were 2.6 and 0.86μg/mL,respectively. All the dissolutions of samples from four manufacturers with-in 90 min were more than 80% of the stated amount. However,the dissolution curves of the samples showed sig-nificant difference.Conclusion:The HPLC method was accurate,reliable and highly sensitive,which distinguished the dissolution characters of products from various manufacturers,and was suitable for the determination of dissolu-tion of ciclosporin soft capsules.关键词
环孢素软胶囊/溶出度/高效液相色谱法Key words
Ciclosporin Soft Capsules/Dissolution/HPLC引用本文复制引用
刘虹,赵海鹏,李源,陈燕..环孢素软胶囊溶出度HPLC检测方法改进研究[J].中国执业药师,2016,13(4):11-15,17,6.
