• Narasimha Rao Avupati
• Prof. Dr. Nageswara Rao Gollapalli
• Moses Babu

An analytical method has been developed for trace level determination of 5-Hydroxy-4-Methoxy-2-Nitro benzoic acid (potential genotoxic impurity) in drug substances at pharmaceutical industry.The accurate Quantitation of 5-Hydroxy-4-Methoxy-2-Nitro benzoic acid was achieved on Eclipse XDB C8 (250mm x 4.6mm, 5.0µm) column with gradient elution at a flow rate of 1.0mL/min. Gradient elution containing mobile phase-A and mobile phase-B, 0.1% of Ortho phosphoric acid in water used as mobile phase-A and Acetonitrile used as mobile phase-B. The elution of 5-Hydroxy-4-Methoxy-2-Nitro benzoic acid is monitored at 210nm, by using Ultra Visible / PDA detector at the level of 3ppm. The high correlation coefficient (R2>0.9999) values indicated clear correlations between the investigated compound concentrations and their peak areas within the LOQ (limit of Quantitation) to 150% level. 5-Hydroxy-4-Methoxy-2-Nitro benzoic acid was uses in manufacturing process of Gefitinib. Hence 5-Hydroxy-4-Methoxy-2-Nitro benzoic acid was major possible and potential genotoxic impurities of Gefitinib.

5-Hydroxy-4-Methoxy-2-Nitro benzoic acid; Genotoxic impurity; HPLC; Gefitinib.

"Trace Level Determination Of Potential Genotoxic Impurity 5-Hydroxy-4-Methoxy-2-Nitro Benzoic Acid In Drug Substance", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.6, Issue 3, page no.249-259, March-2019, Available :http://www.jetir.org/papers/JETIR1903832.pdf

"Trace Level Determination Of Potential Genotoxic Impurity 5-Hydroxy-4-Methoxy-2-Nitro Benzoic Acid In Drug Substance", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.6, Issue 3, page no. pp249-259, March-2019, Available at : http://www.jetir.org/papers/JETIR1903832.pdf