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ABSTRACT
The chemical stability of scopolamine hydrobromide in nasal solution has been studied by using a stability-indicating high-performance liquid chromatographic assay method that was developed in our laboratory. The concentrations of the drug were directly related to peak heights, and the percent relative standard deviation based on five injections was 0.4. The products of decomposition and excipients present in the dosage forms did not interfere with the developed assay method. The nasal solution was stable for at least 42 days when stored in amber-colored glass bottles at room temperature. The physical appearance and the pH value of the nasal solution did not change during the study period.
INTRODUCTION
Scopolamine hydrobromide (HBr) trihydrate (Figure 1) is a naturally occurring anticholinergic drug known as hyoscine. Intranasal solution of the drug can provide a noninvasive, reliable, fast, and effective method for controlling nausea. A formula for compounding the nasal solution of this drug has been reported.1 The stability studies on this recommended formulation were not conducted.1
The purposes of these investigations were (1) to develop a stability -indicating highperformance liquid chromatography (HPLC) assay method for the quantitation of scopolamine HBr and (2) to study the chemical stability of scopolamine HBr in nasa' solution.
MATERIALS AND METHODS
Chemicals and Reagents
All the chemicals and reagents were United States Pharmacopiea- National Formulary or American Chemical Society grade and were used without further purification. Scopolamine HBr trihydrate powder (Lot 104882) was generously supplied by Professional Compounding Centers of America (Houston, Texas).
Equipment
An HPLC system (ALC 202 pump...