Kirchhoefer R D, Hipp S
U.S. Food and Drug Administration, Division of Drug Analysis, St. Louis, MO 63101-2045.
J AOAC Int. 1993 Mar-Apr;76(2):394-8.
Automated and manual procedures were developed to obtain dissolution profiles of sustained-release niacin formulations. The procedures are based on the United States Pharmacopeia XXII apparatus 1 (basket) at 100 rpm with 900 mL 0.1N HCl as the dissolution medium. Filtered aliquots are read at 260 nm. No interference was found from excipients. The procedures are straightforward and will discriminate between sustained-release and regular niacin formulations.
已开发出自动和手动程序来获取缓释烟酸制剂的溶出曲线。这些程序基于《美国药典》第二十二版装置1(篮法),转速为100转/分钟,以900毫升0.1N盐酸作为溶出介质。过滤后的等分试样在260纳米处读取。未发现辅料有干扰。这些程序简单明了,能够区分缓释烟酸制剂和普通烟酸制剂。