Method to develop the stability-indicating LC method.

Method OptimizationDifferent chromatographic conditions were experienced to develop the stability-indicating LC method.

The UPLC method was optimized through the evaluation of different buffers and organic solvents. The use of 0.002M of dipotassium hydrogen phosphate and acetonitrile in a ratio of 53:47%v/v on BEH C18; 50×2.1mm; 1.

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7µm column was found to furnish sharp, well-defined peak with good resolution and low retention time of about 2.69 min at a flow rate 0.6 ml/min. The peak was monitored at 210nm.System SuitabilityThe System suitability of the method was determined by five replicate injections of 2.0?l of standard solution through an autosampler injector and the chromatograms were recorded.

The system suitability parameters were measured and the results are shown in Table 1. The results have been demonstrated with respect to %RSD, resolution and USP tailing factor. The %RSD of replicating injections was less than 1. The results will make sure transferability of the method and amplify the consistency of the results obtained.


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