HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHIC METHOD FOR ASSAY OF OTILONIUM BROMIDE, DIAZEPAM, AND RELATED-COMPOUNDS IN FINISHED PHARMACEUTICAL FORMS

被引:16
作者
MANNUCCI, C [1 ]
BERTINI, J [1 ]
COCCHINI, A [1 ]
PERICO, A [1 ]
SALVAGNINI, F [1 ]
TRIOLO, A [1 ]
机构
[1] A MENARINI IND FARMACEUT RIUNITE SRL,ANALYT RES DEPT,VIA SETTE SANTI 3,I-50131 FLORENCE,ITALY
关键词
D O I
10.1002/jps.2600820406
中图分类号
R914 [药物化学];
学科分类号
100701 ;
摘要
A rapid, simple, stability-indicating assay procedure for otilonium bromide, a smooth muscle relaxant agent, and diazepam in composite tablet analysis was developed with high-performance liquid chromatography. The tablet matrix was dissolved with water, and drugs were extracted with acetonitrile containing an internal standard. An aliquot was centrifuged and chromatographed on a 5-mum, reversed-phase column with 0.5 M sodium acetate trihydrate buffer containing 5 mM 1-heptanesulfonic acid monohydrate sodium salt:methanol (30:70; v/v; adjusted to pH 6.0 with glacial acetic acid) as the mobile phase. The selectivity of the chromatographic system was demonstrated by resolving both compounds from various potential degradation products of each compound. The method is linear, quantitative, and reproducible.
引用
收藏
页码:367 / 370
页数:4
相关论文
共 6 条
[1]  
CORTI P, 1990, PHARM ACTA HELV, V65, P189
[2]  
FLOREY K, 1972, ANAL PROFILES DRUG S, V1, P91
[3]  
Fontani F, 1987, Boll Chim Farm, V126, P66
[4]   QUATERNARY-SALTS OF SUBSTITUTED 2-AMINOETHYL N-BENZOYLAMINOBENZOATE - NEW CLASS OF SMOOTH MUSCLE RELAXANT AGENTS [J].
GHELARDONI, M ;
PESTELLINI, V ;
PISANTI, N ;
VOLTERRA, G .
JOURNAL OF MEDICINAL CHEMISTRY, 1973, 16 (09) :1063-1065
[5]  
SIGNORINI C, 1984, DRUG EXP CLIN RES, V10, P273
[6]  
1989, US PHARMACOPEIA, P1566