Abstract:

Using the quality by design concept (QbD) and a DoE methodology to identify the design space for a technique of Related impurities method for Clofarabine API, Clofarabine parenteral dosage form, and reconstitution studies using 0.9 percent sodium chloride. Using design expert software, DoE was used to do a simultaneous multivariant approach for pH, buffer strength in the mobile phase, and flow rate. Trials were done in a two-level fractional factorial design (2 4-1 + 4 canter points = 12 experiments) to establish design space. Method development experiments were performed by using a composite degradation sample with spiked known impurities. Degradation unknown and known impurity pairs were studied statistically to identify the chromatographic parameters essential for their resolution. Various data tables, such as analysis of variance and Pareto charts, were used to assess conclusions made during this process. The 'design space' of the method's chromatographic factor range was shown in the plot of desirability. The procedure is exact, specific, accurate, and reliable all at once. This method is found suitable for the quantification of impurities in Clofarabine API, Clofarabine parenteral dosage form, and reconstitution studies.

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