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Isocratic Analysis Essay

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ABSTRACT A Novel, fast, accurate and précised method has been developed and validated for the identification of Genotoxic impurities in omeprazole. Chromatographic analysis was performed on Zorbax SB-phenyl (100 x 4.6 mm, 5µm), YMC pack pro (C18, 100 x 4.6mm, 3µm), Kinetic ( C18 ,150x4.6 mm, 5µm), YMC pack pro( C18 ,100 x 4.6mm, 5µm) column . Mobile phase used as Buffer (0.1% formic acid in water): Methanol (40:60). Isocratic analysis was performed on Acquity LC-MS/MS range 221nm with a flow rate of 1 ml/min .The retention time for Genotoxic impurities in omeprazole was 3.496, the linear response as found to be in a concentration range of 50-150 g/ml with a correlation of 0.999. Hence the developed method is simple, fast, accurate and …show more content…

The solution was filtered through 0.22 µm membrane filter and degassed by sonicate for 5minutes. Mobile phase A: 0.02M ammonium acetate buffer PH 4.0 Mobile phase B: Methanol The mobile phase was prepared by mixing Mobile phase A and Mobile phase B in the ratio of 35:65.Then it was filtered and degassed. The trial plot was shown in figure Diluent preparation: Taken 1000ml of methanol into a 1 litre mobile phase bottle, mixed well and degassed by sonicating for 5 minutes. Chromatographic conditions Instrument : LC-MS/MS 8030 Column : YMC pack pro C18 ,100 x 4.6mm, 3µm Flow rate : 1. ml/min Column temperature : Ambient Injection volume :

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