Acceso usuarios
Abstract: Nitrite is present everywhere including water, solvents, and the environment. When it combines with amides and secondary amines, leads to generation of N-nitrosamines, that behave as a carcinogenic agent.
During the production drug or products may have these impurities such as N-nitrosamines due to the employ- ment of reagents, catalysts, solvents, or raw ingredients, which has amides or secondary amines groups dur- ing. Therefore, determination of nitrite content is very important at initial stage to find out the possible of N- nitrosamines. Different approaches have been used to determine the nitrite content in the various samples.
During this research, an optimized and improved method for the determination of nitrite content was utilized.
0.1 ppm limit for nitrite concentration in pharmaceutical products can be found using the Reverse Phase HPLC technique with Fluorescence Detection. This process produces 2,3-naphthotriazole (NAT) by pre-column deri- vatization of nitrite with 2,3-Diaminonapthalene (DAN) in an acidic medium. Chromatographic separation was accomplished on an Xbridge BEH C8 (150 x 4.6) mm, 2.5 μm column using a gradient elution technique based on buffer pH 7.0 and acetonitrile as the mobile phase to determine NAT. At 415 nm for emission and 375 nm for excitation, the absorbance of NAT was measured. This technique could be very crucial for the detection of nitrite substances, that might lead to production of carcinogenic substances such as N-nitrosamines. In this way, we can avoid usage of these substances in pharmaceutical industry.
