Methods for Assay, Related Substances, and Organic Volatile Impurities in Triazolam Raw Materials and Formulations

Abstract

Abstract Liquid chromatographic methods have been developed for determination of triazolam and related compounds in drug raw materials and tablets. The methods resolve 9 available related compounds from the drug with quantitation limits of 0.1 % or less. Eight raw materials and 16 formulations were examined for related compounds. Total impurities in raw materials ranged up to 0.6% and up to 1% in formulations, not including a compound in some tablets that is believed to be excipient related. Assay values were between 99.9 and 101.3% for raw materials and between 89.4 and 105.5% for tablets. A gas chromatographic method was developed for organic volatile Impurities in drug raw materials. The major solvents found were methyl ethyl ketone (100-750 ppm), ethyl acetate (510 ppm), and n-propanol (80-300 ppm), with a trace of benzene (<30 ppm) in several samples.