This sector includes the part of product development that evaluates the quantification of Active Pharmaceutical Ingredients (API) in developed formulations. For this purpose, high-performance liquid chromatographs (HPLC) are used, which are efficient in detecting and quantifying the vast majority of drugs, whose active ingredients come from organic compounds, in addition to the versatility of being able to evaluate other types of compounds, such as ionic salts, dextrorotatory and levorotatory substances and fluorescent substances, varying their detection modules.
Here, analytical methods are developed covering all validation topics, such as robustness, selectivity, specificity, linearity, precision, accuracy, detection limit and quantification.
With these resources, it is also possible to evaluate the uniformity of the API content of batches produced, in pharmaceutical products that are already on the market, and make comparisons that can attest “in vitro”, together with the dissolution sector, the interchangeability between generic and similar drugs with the reference product on the market.
