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Tablet Dissolution for Content Uniformity Testing and HPLC Assay

Ultrasonic energy, applied in a process called sonication, is widely used to dissolve pharmaceutical tablets for HPLC assay procedures such as content uniformity testing. Many methods detailed by the USP recommend using an ultrasonic bath to extract the active pharmaceutical ingredient (API) from tablet formulations.

When preparing pharmaceutical samples for HPLC assay care must be taken to avoid chemical degradation of the API due to excessive heat. For this reason it is important that sonication is accomplished quickly as the process itself generates heat. One way to achieve this goal is to use a pharmaceutical tablet sonicator kit, the components of which enable the completion of tablet dissolution up to 16 times faster than conventional systems.

These tabletop tablet sonication kits include specially designed racks to position sample flasks at just the right depth in an ultrasonic bath to allow maximum acoustic energy to reach the flasks. The sonicating bath consists of water and an optional sonic amplifier additive to enhance cavitation.

Sample preparation typically involves grinding the samples (taking care that this itself does not generate heat) and placing them in the flasks containing a suitable solvent. The flasks are then placed in the specially designed sonication racks. The 3-gallon kit has a capacity of 15, 100-mL flasks in a single rack and the larger 6-gallon kit holds up to 24, 100-mL flasks in two racks. Ultrasonic energy penetrates the flask walls to dissolve the samples.

The tablet sonication kits operate at 320 and 415 watts respectively with energy transmitted into the bath by 42 kHz ultrasonic transducers. The high ultrasonic power assures maximum recovery of API, critical for HPLC assay methods including dose content uniformity testing. Along with minimizing heat buildup the sonicator kit design minimizes transducer burn marks and flask etching. Other kit components include a timer, a drain to facilitate changing the bath, and a cover to protect the bath when not in use.

After use, the flasks themselves should be rinsed and thoroughly cleaned in an ultrasonic cleaner, rinsed again with distilled or DI water to avoid spotting, dried and inspected for chips or cracks. They then can be used for further tests.


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