A comparative study of intravenous midazolam marketed in Libya

Midazolam, a benzodiazepine medication, is used for sedation during diagnostic and therapeutic medical procedures. Insufficient doses of sedatives, including midazolam, can result in patient anxiety and awareness during the procedure. Several brands of midazolam are available in the Libyan market. This study aims to identify and estimate the medication content of intravenous midazolam in various marketed products using different analytical methods. Product identity was confirmed using Infrared methods (IR) and retention times of High-Performance Liquid Chromatographic methods (HPLC). Quantification was performed using a rapid reverse-phase HPLC method. Chromatographic analysis was conducted on a C18 column (250 mm×3.3 mm I.D., 5.0 μm particle size) with a mobile phase comprising acetonitrile, methanol, and 0.065 M ammonium acetate buffer (50: 20: 30, v/v/v), adjusted to a pH of 5.5±0.02 with orthophosphoric acid, at a flow rate of 1.0 ml/min. Ultraviolet (UV) detection was set at 220 nm. The identification results met British Pharmacopeia (BP) standards. However, the midazolam content in the Tunisian brand was shallow compared to the products from Germany and Switzerland. Thus, post-marketing testing is essential to assess the quality of critical drugs like midazolam, and further investigations, including clinical evaluations and regulatory follow-up, are necessary.