ABSTRACT
A stability-indicating UV assay was developed for xilobam, a member of a new class of CNS agents. The method was specific, precise, and accurate. TLC and high-pressure liquid chromatography were used to support method specificity. Xilobam is sensitive to heat, moisture, and basic conditions. The degradation products were identified as N-methylpyrrolidone, 2,6-dimethylaniline, and N,N'-bis(2,6-dimethyl-phenyl)urea. At high temperatures, the incorporation of molecular sieves into glass bottles of xilobam tablets was effective in preventing decomposition caused by moisture or volatile decomposition products.
Subject(s)
Phenylurea Compounds/analysis , Pyrrolidines/analysis , Chromatography, High Pressure Liquid/methods , Chromatography, Thin Layer/methods , Drug Stability , Hydrogen-Ion Concentration , TabletsABSTRACT
An accurate, rapid, and specific high-performance liquid chromatographic (HPLC) assay was developed for codeine in acetaminophen with codeine combination products. The internal standard (chlorpheniramine maleate), codeine, acetaminophen, and several other test compounds or impurities were well separated. A complete analysis took < 10 min. The relative standard deviations of the retention time, precision, and accuracy were 0.5, 0.4, and 0.5%, respectively. An excellent linear correlation was obtained between the HPLC and GLC methods.
Subject(s)
Codeine/analysis , Acetaminophen/analysis , Chlorpheniramine/analysis , Chromatography, Gas , Chromatography, High Pressure Liquid/methods , Drug Combinations , Tablets/analysisABSTRACT
A spectrophotometric assay for determining tolmetin sodium in pharmaceutical solid dosage forms is described. Tolmetin sodium is separated from common pharmaceutical excipients and probable degradation products. Recovery, precision, and accuracy data are provided. Two TLC methods are included which can be used to monitor qualitatively the stability of aged dosage forms.
Subject(s)
Pyrroles/analysis , Tolmetin/analysis , Chromatography, Thin Layer , Drug Stability , Hydrolysis , Methods , Tablets/analysisABSTRACT
The determination of propoxyphene hydrochloride by gas chromatography (GC) has been examined. Under a number of operating conditions significant on-column decomposition has occurred. The amounts of decomposition have been found to be dependent on sample size, flow-rate, column temperature, liquid phase loading, and solid support material. In view of this work a high-pressure liquid chromatographic procedure for quantitating propoxyphene hydrochloride has been developed. This method has been found to be specific for propoxyphene hydrochloride in the presence of its heat decomposition products formed with and without acetaminophen. This method does not suffer from problems associated with GC procedures.
