Comparative Test of Midazolam Hydrochloride Stability in Different Storage and Temperature Container

Abstract

Background: Midazolam hydrochloride is an injection form of benzodiazepines and included in the high
alert category in the Dr. Soetomo Teaching Hospital Intensive Care Unit (ICU), Surabaya, Indonesia.
Nowadays, the technical preparation of midazolam drugs in the ICU room by doctors and nurses was
performed by reconstituting drugs in the injection syringes to be stored for a while in the room. Objectives:
To evaluate the preparation process for midazolam hydrochloride injection which has been analyzed in
Dr. Soetomo Teaching Hospital. Methods: Physical, chemical, and microbiological stability of 1 mg/mL
midazolam hydrochloride in aqua pro injection solvents have been evaluated at points 0, 8, 12, and 24 hours
after preparation, as well as a comparison of stability in storage conditions at room temperature compared
to refrigerator temperatures. Results: The results showed all the preparations were no foreign particles
in the sample container. The midazolam did not experience precipitation in both room and refrigerator
temperatures. The pH of midazolam solution during storage proved that the preparation was relatively stable
(pH 4.3–4.5). There were no significant differences of midazolam levels in both storages which was in range
of 95%. The Miccrobiology Stability Test showed negative germ growth after 24 hours incubation in both
storage. Conclusion: This study showed no changes in physical, chemical, or microbiological stability in the
midazolam injection samples up to 24 hours after the manufacturing process.