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

• Main Authors: Anang Endaryanto, -, Andang Miatmoko, -, Mela Dwi Wulandari, -, Novi Aryanti, -
• Format: Article PeerReviewed
• Language: English; English; English
• Published: Institute of Medico-Legal Publications 2020
• Subjects: R Medicine; RS Pharmacy and materia medica; RS1-441 Pharmacy and materia medica; RS200-201 Pharmaceutical dosage forms
• Online Access: https://repository.unair.ac.id/123694/1/C-14%20Artikel.pdf; https://repository.unair.ac.id/123694/2/C-14%20Kualitas%20Karil.pdf; https://repository.unair.ac.id/123694/3/C-14%20Similarity.pdf; https://repository.unair.ac.id/123694/; https://medicopublication.com/index.php/ijfmt/article/view/11624; https://doi.org/10.37506/ijfmt.v14i4.11624
• Institution: Universitas Airlangga

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.