Effect of temperature and relative humidity on nitrazepam stability in solid state.
The decomposition of a 1% dilution of nitrazepam in microcrystalline cellulose was established by quantitative determination of the two main breakdown products, 2-amino-5-nitrobenzophenone and 3-amino-6-nitro-4-phenyl-2(1H)-quinolone, using in situ diffuse reflectance measurements on thin-layer chromatograms. The decomposition and formation rate constant of nitrazepam and of the breakdown products, respectively, were determined at four temperatures and six relative humidities. By means of a three-parameter regression equation, it was possible to correlate quantitatively the decomposition constant of nitrazepam to both temperature and relative humidity.
D002855:Chromatography, Thin Layer; D004355:Drug Stability; D004356:Drug Storage; D006813:Humidity; D007700:Kinetics; D009567:Nitrazepam / Q000032:analysis; D013696:Temperature; D013997:Time Factors
D009567:Nitrazepam