title: Chemical stability of midazolam injection by high performance liquid chromatography.
abstract: 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.
authors.affiliation: Pharmacy Department, Pharmacy School, University of Concepción, Concepción, Chile. mdediego@udec.cl
authors.forename: Marta
authors.initials: M
authors.lastname: de Diego
authors.forename: Gloria
authors.initials: G
authors.lastname: Godoy
authors.forename: Sigrid
authors.initials: S
authors.lastname: Mennickent
mesh_terms: D002623:Chemistry Techniques, Analytical / Q000379:methods; D002845:Chromatography / Q000379:methods; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D002853:Chromatography, Liquid / Q000379:methods; D004355:Drug Stability; D006863:Hydrogen-Ion Concentration; D008874:Midazolam / Q000032:analysis* / Q000737:chemistry; D008956:Models, Chemical; D010710:Phosphates / Q000737:chemistry; D015203:Reproducibility of Results; D013696:Temperature; D013997:Time Factors
chemical_list: D010710:Phosphates; D008874:Midazolam