Legnerová Z, Huclová J, Thun R, Solich P
Department of Analytical Chemistry, Faculty of Pharmacy, Charles University, Heyrovského 1203, 50005 Hradec Králové, Czech Republic.
J Pharm Biomed Anal. 2004 Jan 27;34(1):115-21. doi: 10.1016/j.japna.2003.08.014.
This report introduces a fully automated flow system for drug-dissolution studies based on the coupling of the sequential injection analysis (SIA) technique with a conventional dissolution apparatus. The methodology described was used for monitoring of dissolution profiles of prazosin hydrochloride (PRH) in pharmaceutical formulation. The very sensitive fluorimetric detection of PRH was performed at lambda(ex)=244 nm (lambda(em)>or=389 nm). Under the optimal conditions, the calibration curve was linear over the range 0.02-2.43 mg x l(-1) of PRH with R.S.D. 1.89, 1.23, and 1.80% (n=10) when determining 0.02, 1.22, and 2.43 mg x l(-1) of PRH in standard solutions, respectively. Equation of the calibration curve was calculated giving the following values: F=4.108 c-3.9 (n=6), r=0.9996. Detection limit was calculated 0.007 mg x l(-1) of PRH. The dissolution test of Deprazolin tablets was programmed for 60 min, with a continuous sampling rate of 70 h(-1) under conditions required by USP 26. Results obtained by SIA technique compared well with HPLC standard method.
本报告介绍了一种基于顺序注射分析(SIA)技术与传统溶出度仪联用的用于药物溶出度研究的全自动流动系统。所描述的方法用于监测药物制剂中盐酸哌唑嗪(PRH)的溶出曲线。PRH的极灵敏荧光检测在λ(ex)=244nm(λ(em)≥389nm)下进行。在最佳条件下,校准曲线在0.02 - 2.43mg·L⁻¹的PRH范围内呈线性,当分别测定标准溶液中0.02、1.22和2.43mg·L⁻¹的PRH时,相对标准偏差分别为1.89%、1.23%和1.80%(n = 10)。计算得到校准曲线方程如下:F = 4.108c - 3.9(n = 6),r = 0.9996。计算出PRH的检测限为0.007mg·L⁻¹。按照美国药典26版要求的条件,对Deprazolin片剂进行60分钟的溶出度测试,连续进样速率为70h⁻¹。SIA技术获得的结果与HPLC标准方法的结果比较吻合。