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High-performance Liquid Chromatographic Method for Assay of Otilonium Bromide, Diazepam, and Related Compounds in Finished Pharmaceutical Forms

C Mannucci, J Bertini, A Cocchini, A Perico, F Salvagnini, A Triolo

J Pharm Sci. 1993 Apr;82(4):367-70.

PMID: 8468679

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.

Chemicals Related in the Paper:

Catalog Number Product Name Structure CAS Number Price
AP207300901 Sodium 1-heptanesulfonate monohydrate Sodium 1-heptanesulfonate monohydrate 207300-90-1 Price
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