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An Ultra High Pressure Liquid Chromatographic method was developed for the estimation of Maraviroc in bulk and in formulations. The separation was achieved on X bridge (C18 20 x 4.6 mm, 2.5μ column) using 0.01M potassium dihydrogen phosphate (KH2PO4) (pH 7.0 adjusted with ortho phosphoric acid) and acetonitrile (60:40) as mobile phase. The flow rate kept at 0.5 mL/min, column temperature 30oC, and the column eluents were monitored at 210 nm. The forced degradation studies were done to show stability indicating power of the method. The method has been validated accordance with ICH guidelines for specificity, precision, accuracy, linearity, limit of detection, limit of quantification, robustness and ruggedness. The results were found to be well within the limits. The method can be used for the routine analysis of Maraviroc bulk and in formulations.
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Author(s): M Geetha G Lalitha Dr Shakil Sait
Ultra High Pressure Liquid Chromatography, Maraviroc ICH guidelines, Validation