A simple, sensitive, and straight forward LC-MS approach for rapid analysis of three potential genotoxic impurities in rabeprazole formulations was written by Yenugu, Veera Manohara Reddy;Ambavaram, Vijaya Bhaskar Reddy;Moniruzzaman, Muhammad;Madhavi, Gajulapalle. And the article was included in Journal of Separation Science in 2018.Synthetic Route of C18H20N3NaO3S The following contents are mentioned in the article:
In the present study, a sensitive and fully validated liquid chromatog. with mass spectrometry method was developed for the quantification of three potential genotoxic impurities in rabeprazole drug substance. The separation was achieved on Symmetry C18 column (100 脳 4.6 mm, 3.5 渭m) using 0.1% formic acid in water as mobile phase A and acetonitrile as mobile phase B in gradient elution mode at 0.5 mL/min flow rate. Triple quadrupole mass detection with electrospray ionization was operated in selected ion recording mode for the quantification of impurities. The calibration curves were demonstrated good linearity over the concentration range of 1.0-4.5 ppm for O-phenylenediamine, 1.8-4.5 ppm for 4-nitrolutidine-N-oxide and 1.0-4.5 ppm for benzyltriethylammonium chloride with respect to 10 mg/mL of rabeprazole. The correlation coefficient obtained in each case was >0.998. The recoveries were found satisfactory over the range between 94.22 and 106.84% for all selected impurities. The method validation was carried out following International Conference on Harmonization guidelines, from which the developed method was able to quantitate the impurities at 1.0 ppm for O-phenylenediamine, 1.8 ppm for 4-nitrolutidine-N-oxide and 1.0 ppm for benzyltriethylammonium chloride. Furthermore, the proposed method was successfully evaluated for the determination of selected impurities from bulk drug and formulation samples of rabeprazole within the acceptable limits. This study involved multiple reactions and reactants, such as Sodium 2-(((4-(3-methoxypropoxy)-3-methylpyridin-2-yl)methyl)sulfinyl)benzo[d]imidazol-1-ide (cas: 117976-90-6Synthetic Route of C18H20N3NaO3S).
Sodium 2-(((4-(3-methoxypropoxy)-3-methylpyridin-2-yl)methyl)sulfinyl)benzo[d]imidazol-1-ide (cas: 117976-90-6) belongs to imidazole derivatives. Among the different heterocyclic compounds, imidazole is better known due to its broad range of chemical and biological properties. Imidazole has become an important synthon in the development of new drugs. Imidazole is incorporated into many important biological compounds. The most pervasive is the amino acid histidine, which has an imidazole side-chain. Histidine is present in many proteins and enzymes, e.g. by binding metal cofactors, as seen in hemoglobin.Synthetic Route of C18H20N3NaO3S
Referemce:
Imidazole – Wikipedia,
Imidazole | C3H4N2 – PubChem