Analytical method transfer is the process of transferring a validated analytical procedure from an originating laboratory to another laboratory. Analytical method transfers are particularly useful in pharmaceutical analysis and often performed for dissolution testing. Dissolution tests provide an in vitro study of the rate of release of the active pharmaceutical ingredient in drug tablets. The objective for this investigation is to provide dissolution analysis of potassium gluconate tablets for determining the concentration in ppm and average percent recovery of the drug upon dissolution. The 595.7 mg potassium gluconate tablets were assayed for dissolution rate using apparatus 2, as described by the USP. The dissolution samples were analyzed after 45 and 75 minutes by the Varian SpectrAA 220. Each sample solution was micro filtered prior to instrumentation. The average concentration and percent recovery of the tablets after 45 and 75 minute dissolution were 0.56 �0.03 ppm with a 101�5 % recovery and 0.57 �0.03 ppm with a 104�5 % recovery, respectively. Filter validation was then performed for comparison of detected concentrations in unfiltered versus micro filtered samples. The average concentration of the unfiltered and filtered solutions were 0.530 ppm and 0.54 �0.02 ppm, respectively. The average percent recovery for the filtered samples was 101 �6 %.

Dissolution analysis of potassium gluconate tablets: The first step in an analytical method transfer

248th National Meeting (2014)

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