![]() The fact that the API mass percent in tablet medications can be determined non-destructively, without sample preparation, and within a few minutes makes Raman spectroscopy ideal for these applications. Knowledge of the API mass, or mass percentage, is essential in the development and quality control of drug product formulations, as well as in the identification of counterfeit drug products. In the past two decades, Raman spectroscopy has become an important analytical tool for determining the amount of a pharmaceutical active ingredient (API) in solid dose medications. The data suggest that this simple method could be used to pass or fail manufactured drug product batches in accordance with the US Pharmacopeia method for content uniformity, without knowledge of the excipients. The Raman spectra of the 30 generic tablets were then fit with weighted percents of the pure loratadine spectrum and the created excipient spectrum, and used to determine a mean API mass for the tablets of 10.12 ± 40 mg, again meeting the acceptance value for the 10 mg API product. A Raman spectrum representative of all excipients was created by subtracting the API Raman spectrum from the product spectrum. The method was then applied to a generic version of the Claritin product that employed different excipients of unknown mass percents. The mean loratadine mass of 9.79 ± 40 mg per 100 mg tablet compared favorably to the 10.21 ± 0.63 mg per 100 mg tablet determined using high-performance liquid chromatography, both of which met the acceptance value to pass the 10 mg API product as labelled. The method was developed by fitting the Raman spectra of 30 Claritin ® tablets with weighted percentages of the Raman spectrum of its API, loratadine, and a composite spectrum of the known excipients. And further, we demonstrated the ability of the method to pass or fail a manufactured drug product batch based on a calculated acceptance value in accordance with the US Pharmacopeia method for content uniformity. ![]() Here we present a simple method to determine the active pharmaceutical ingredient (API) mass percent in a sample that does not require knowledge of the identities or relative mass percents of the inactive pharmaceutical ingredients (excipients). ![]() Raman spectroscopy has proven valuable for determining the composition of manufactured drug products, as well as identifying counterfeit drugs. ![]()
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