Trace determination of the antihistamines tripelennamine hydrochloride, thenyldiamine hydrochloride, and chlorothen citrate in admixture in animal feed, human urine, and wastewater by high-pressure liquid chromatography and use of a fluorescence detector

Abstract

Tripelennamine hydrochloride, thenyldiamine hydrochloride, and chlorothen citrate have been used as antihistamines and for the treatment of asthma and bronchitis. Toxicological evaluation of these drugs was scheduled as part of a structure-activity relationship study of antihistamines in rats and mice, because of the paucity of such information. Prerequisite for the evaluation was the development of analytical chemical procedures to certify the concentration, homogeneity, and stability of the drugs in dosed feed, to monitor the urine of laboratory personnel to signal their possible exposure to the drugs, and to monitor the wastewater to ensure that the test agents were not discharged into the environment. A high-pressure liquid chromatographic procedure with fluorescence detection was developed for determination of the three antihistamines in admixture in animal feed, human urine, and wastewater at levels of 500, 10 and 10 ng g , respectively. Data on the partition values and use of a silica gel column to aid in the clean-up of sample extracts from the three substrates are reported for the three test agents. Extraction efficiencies and data concerning the stability of tripelennamine hydrochloride and thenyldiamine hydrochloride in animal feed are presented. Description of a new route for synthesis of chlorothen citrate and ancillary data concerning the gas chromatographic analysis for the three drugs in admixture in animal feed at levels as low as 10 μg g are also reported.