The purpose of this study was to optimize the dissolution model of sunitinib malate released from gelatine capsules and then to quantify the released amount of the active substance by the appropriate  HPLC and spectrophotometric analytical methods.

The study was carried out on the reference capsules  Sutent  12,5 mg, 25 mg and 50 mg manufactured by Pfizer Ltd.

The dissolution was performed using the USP apparatus 1, with baskets rotating at 100 rpm and a 900 ml of  the dissolution medium.

The dissolution conditions were optimized  through the appropriate  choice of a dissolution medium.  It was not possible to achieve the sufficient dissolution level using hydrochloric acid (0,1 mol/l) as the dissolution medium, although sunitinib malate is not difficult to dissolve in water. The addition of a surfactant to the dissolution medium was required.  The final choice of different  surfactant  amounts was made by comparing the dissolution profiles. The dissolution profiles were developed in the range from the time point of 5 minutes to the point when over 85% of the active substance was released and later compared in relation to the  results obtained by the HPLC and spectrophotometric methods.

Two analytical methods -  the selective and not highly time-consuming reversed-phased HPLC and the spectrophotometric one were developed for the quantitation of the amount of the active substance released from the capsules. Both methods were validated in accordance with the International Conference on Harmonization (ICH) requirements.

Both methods can be used to assay the amount of sunitinib malate released from capsules.

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