Background:
Early antidepressant Active Pharmaceutical Ingredients (API) like Imipramine hydrochloride and Clomipramine hydrochloride have not been assessed for Genotoxic Impurities (GTI) as per ICHM7.
Objective:
The main aim of the study was to develop a new simple and sensitive method for the determination of genotoxic impurities in Imipramine hydrochloride and Clomipramine hydrochloride active pharmaceuticals ingrediens.
Methods:
A simple, selective, and sensitive gas chromatography (GC) liquid injector method was developed for the quantitative determination of N, N-Dimethyl amino propyl chloride (DAPC) in API s. This method provided an excellent sensitivity and a typical target analyte level of 4.0 ppm. The DPAC content in the sample was analyzed on ZB-624, 30m x 0.53mm x 3.0μm column interfaced with a flame ionization detector (FID). The developed method was validated as per ICH guidelines.
Results:
The validated method showed good linearity over the concentration range of LOQ to 120% (1.18ppm to 4.8ppm) with a correlation coefficient of 0.9986. Limit of detection (LOD) and limit of quantitation (LOQ) were found to be 0.36 ppm and 1.18 ppm, respectively. This method showed high sample recovery (>90.0%).
Conclusion:
The developed method was a simple and sensitive gas chromatography liquid injector method. This method was validated as per ICH guidelines and could be very useful for the determination of a potential genotoxic impurity (DAPC) in imipramine hydrochloride and clomipramine hydrochloride active drug substance quality checking and ensuring safety of the patients.
Nickel-based electrodeposits are extensively used to protect mild steel. The graphene-based materials as corrosion resistive coatings for metallic substrates have been attracted researchers due to their ability to prevent the metal surface. Herein, nickel and nickel reduced graphene oxide (Ni-rGO) composite coatings have been electrodeposited on mild steel using sulphate bath solution. The morphological results reveal that the Ni-rGO coatings exhibited a smaller grain size with less surface defects. It was observed from the scanning electron micrographs images that composite coatings are porous free. The anti-corrosion properties of coatings were further examined by salt spray test. The electrochemical polarization and impedance measurements revealed that Ni-rGO coating enhances the corrosion resistance of mild steel. Electrochemical measurements revealed that the insertion of a few-layered rGO to the Ni matrix increases the corrosion resistance properties of the Ni-rGO coatings.
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