Abstract:
OBJECTIVE To establish a dissolution method of fluvastatin sodium capsules, which deal with the possible cross-linking of gelatin capsules in dissolution test
in vitro. It helps provide reference for revising the current quality standards.
METHODS Dissolution methods in current standards at home and abroad, consistency evaluation of two domestic products in four media with different pH condition and the average dissolution in water and papain solution were compared to establish the dissolution method. The paddle method was used with rotational speed of 50 r·min
-1, using 500 mL of water as the dissolution medium. The dissolution solution was taken at 30 min and analyzed by HPLC. The dissolution limit was set at 80%. If it does not meet the limit, add another test according to the above method with enzyme solution which contain papain more than 550 U·mL
-1. It should be meet the limit.
RESULTS The dissolution results for batches without cross-linking were consistent in both water and the above papain solution dissolution media, and the average dissolution of cross-linked batches in papain solution increased by 5% to 7%.
CONCLUSION The determination method is highly reproducible, accurate and reliable, which can objectively reflect the dissolution of fluvastatin sodium capsules. It can provide a basis for the reasonable unification and revision of the dissolution test of the current quality standards.