Quality Evaluation of Midazolam Hydrochloride Injection Prepared at the Intensive Care Unit of Dr. Soetomo Hospital

Abstract

Midazolam hydrochloride (MDZ) is a benzodiazepine drug, characterized as a high alert medicine, which is frequently prescribed in the Intensive Care Unit (ICU) of Dr. Soetomo Hospital, Surabaya, Indonesia. This study is, therefore, aimed at evaluating the physicochemical and microbiological stability of 1 mg/mL MDZ solution, prepared by nurses in the ICU of Dr. Soetomo Hospital, Surabaya. The samples were prepared by aseptic techniques using alcohol swap and subsequently stored in different containers, i.e. injection syringe and glass vial, at room and cold temperatures. Furthermore, the samples were evaluated 24 hours after preparation, and the result showed no significant difference in solution clarity, pH, as well as MDZ content, and no microbial contamination was observed. In conclusion, it is suggested that the use of alcohol swab techniques, and diluted MDZ solution prepared in ICU, had good stability and feasible for use on patients.

Keywords: midazolam hydrochloride, pH stability, microbial contamination, HPLC, alcohol swab