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Keith Moore, vice-president of analytical services, Metrics Contract Services discusses gains use in dissolution testing.
For those of us who work in analytical laboratories at contract pharmaceutical development and manufacturing organizations (CDMOs), analyzing dissolution test samples is among the most important work we do. Dissolution is the process of incorporating a solid substance into a solvent (physiological pH aqueous solutions in most cases), forming a solution that allows for identification and measurement as a means of determining the release of a drug from the dosage form. The basic pharmaceutical applications of dissolution include:
UV spectroscopy has long been the pharmaceutical chemist’s traditional method and first option for analyzing the results of dissolution testing for the following reasons:
Another example is validating the testing procedure. Typically, there are more data to collect for HPLC system suitability parameters (e.g., column plate counts, peak symmetry, etc.) during method validation as compared to UV spectroscopy. This reduces time and delivers cost benefits.
Of course, there are situations in which HPLC offers advantages over UV spectroscopy. Depending upon wavelength, type of dosage form (e.g., capsules), and the dissolution medium being used, UV spectroscopy’s capabilities may be limited. Separation via HPLC might be needed for degradation products and excipients that absorb at the same wavelength as the active.
-- Keith Moore, vice-president of analytical services, Metrics Contract Services
Article DetailsPartnerships in Outsourcing Supplement
Vol. 40, No. 13
When referring to this article, please cite it as K. Moore, “UV Spectroscopy Gains Use in Dissolution Testing," Pharmaceutical Technology Partnerships in Outsourcing Supplement 40 (13) 2016.