A simple, selective, accurate, precise and linear RP-HPLC method was developed and validation for simultaneous determination of 3-methylbenzofuran-2-carboxylic acid and its three process related impurities. The IUPAC name of impurities were impurity-A (1-(2-hydroxyphenyl) ethanone), impurity-B (3-methylbenzofuran-2-carbonitrile), impurity-C (3-methylbenzofuran-2-carboxamide). The good effective separation was achieved on a Reversed Phase High Performance liquid chromatography method with UV detection, Agilent SB C18 (250× 4.6 mm, 3.5µm) as stationary phase with binary gradient mode solvent phase A of buffer (pH adjust =3.4, with Acetic acid) and phase B of use acetonitrile. The Flow rate of the mobile phase was 0.9 ml/min. The developed method was validated in terms of system suitability and linearity level 150% (0.75µg/ml) to 0.5% (0.0025µg/ml) limits of detection and quantification the for 3MBCA and its four process related impurities short term and long term stability of the analysts in the prepared solution and robustness, following the ICH guidelines.
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2022: 6.012
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