de Diego M, Godoy G, Mennickent S
Chemical stability of midazolam injection by high performance liquid chromatography. [Journal Article, Research Support, Non-U.S. Gov't]
J Sep Sci 2007 Aug; 30(12):1833-8.
The chemical stability of midazolam hydrochloride injection, undiluted or diluted with dextrose sterile solution, was studied at different storage conditions by LC. The study was performed at room temperature (23 +/- 2 degrees C) under light exposure and light protection, +8 +/- 1 degrees C and -20 +/- 0.5 degrees C, in glass and plastic containers over 14 days with midazolam hydrochloride injection, undiluted or diluted with 5% dextrose sterile solution. Chromatographic separation was carried out on a RP-18(e) column, using a mobile phase consisting of ACN-phosphate buffer (pH 3.3; 0.1 M) (30:70 v/v) at a flow rate of 1.0 mL/min and UV detection at 220 nm. The concentrations of all samples remained greater than 90% of the original concentration. The chromatographic assay exhibited an adequate linearity (r(2) >0.999), selectivity, precision (RSD <3.1), and accuracy (recoveries from 100.46 to 101.40%). Injectable midazolam hydrochloride was chemically stable in all conditions that were studied.
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