title: High-performance liquid chromatographic method for assay of otilonium bromide, diazepam, and related compounds in finished pharmaceutical forms.
abstract: 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-microns, 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.
authors: Analytical Research Department, A. Menarini Industrie Farmaceutiche Riunite s.r.l., Florence, Italy.
authors: C
authors: C
authors: Mannucci
authors: J
authors: J
authors: Bertini
authors: A
authors: A
authors: Cocchini
authors: A
authors: A
authors: Perico
authors: F
authors: F
authors: Salvagnini
authors: A
authors: A
authors: Triolo
mesh_terms: D002851:Chromatography, High Pressure Liquid; D003975:Diazepam / Q000008:administration & dosage / Q000032:analysis*; D010276:Parasympatholytics / Q000032:analysis*; D000644:Quaternary Ammonium Compounds / Q000008:administration & dosage / Q000032:analysis*; D013607:Tablets
chemical_list: D010276:Parasympatholytics; D000644:Quaternary Ammonium Compounds; D013607:Tablets; C013934:octylonium; D003975:Diazepam