There are various methods used for sample preparation and extraction, depending on the type of dosage form being analyzed.
In general, the goal of sample preparation and extraction is to isolate and concentrate the API and impurities from the dosage form matrix, while removing any interfering substances that could affect the accuracy of the analysis. This allows for more accurate and reliable chromatographic analysis of the sample.
After the sample has been prepared and extracted, it can be injected into the chromatography equipment for analysis. Chromatographic techniques, such as high-performance liquid chromatography (HPLC) or gas chromatography (GC), are commonly used to separate and quantify the components in the sample.
In the paper entitled, Speeding Sample Preparation and API Extraction from Solid Oral Dosage Formulations, the authors discuss content uniformity in oral solid dose API testing. They describe a method using PrepEngine (now available from Pion Inc., Billerica, MA) that reduced the preparation time of API extraction from solid oral dosage formulations to be accomplished in less than 10 minutes.
They concluded: "Testing showed that the PrepEngine facilitated rapid and quantitative extraction of APIs and degradation products/impurities from IR and CR pharmaceutical solid oral dosage formulations. Extraction efficiencies and precision were comparable to levels obtained with often more time-consuming and cumbersome manual sample preparation and extraction procedures.
With the capability to process up to 10 samples in parallel, throughput is excellent when compared to that of most semi-automated procedures such as accelerated solvent extraction and the tablet processing workstation. The device is simple and user friendly, and, when coupled with alcoholic solvents such as mixtures of ethanol and methanol or 100% ethanol, allows for the development of a universal sample preparation and extraction approach for SCT formulations."
Contact Pion today to learn more about PrepEngine and how it can help speed sample preparation for content uniformity testing.
