Mannucci C, Bertini J, Cocchini A, Perico A, Salvagnini F, Triolo A
Analytical Research Department, A. Menarini Industrie Farmaceutiche Riunite s.r.l., Florence, Italy.
J Pharm Sci. 1992 Dec;81(12):1175-7. doi: 10.1002/jps.2600811209.
A rapid, simple assay procedure was developed for simultaneous analysis of otilonium bromide, a smooth-muscle relaxant, and diazepam in tablets containing 20 mg of otilonium bromide and 2 mg of diazepam (20:2 tablets) or 40 mg of otilonium bromide and 2 mg of diazepam (40:2 tablets) by "zero-crossing" first-derivative spectroscopy. The tablets were dissolved in 0.01 N HCl, mixtures were centrifuged at 3500 rpm (2472 x g) for 5 min, and first-derivative spectra were recorded. The absolute values of the derivative were measured at 264 nm for determination of otilonium bromide and between 406 and 408 nm (380 nm for analysis of 40:2 tablets) for determination of diazepam. The method is linear, quantitative, and reproducible and can also be used for the tablet dissolution test. Ten tablets of the same batch were analyzed by the described method and by a high-performance liquid chromatographic method, and the results were in good agreement.
已开发出一种快速、简单的测定方法,用于通过“零交叉”一阶导数光谱法同时分析含有20毫克奥替溴铵和2毫克地西泮的片剂(20:2片剂)或含有40毫克奥替溴铵和2毫克地西泮的片剂(40:2片剂)中的平滑肌松弛剂奥替溴铵和地西泮。将片剂溶解于0.01 N盐酸中,混合物在3500转/分钟(2472×g)下离心5分钟,并记录一阶导数光谱。在264纳米处测量导数绝对值以测定奥替溴铵,在406至408纳米之间(对于40:2片剂分析为380纳米)测量导数绝对值以测定地西泮。该方法具有线性、定量且可重现性,还可用于片剂溶出度试验。用所述方法和高效液相色谱法对同一批次的十片进行分析,结果吻合良好。