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Analytical Method Development

The ability to provide accurate, reliable, and consistent data is central to the role of the analytical chemist at Eagle Analytical Services. Method development is the process of proving that an analytical method is acceptable for use in our laboratory to measure the concentration of an API in a specific compounded dosage form.

Full method development procedures are complex, extended, and expensive endeavors. These studies usually are required when data from the analysis is going to be submitted to regulatory authorities for certification of a new or amended drug application. The analytical method is tested extensively for specificity, linearity, accuracy, precision, range, detection limit, quantitation limit, and robustness.

For established pharmaceutical preparations, which are not new drug species, the analytical method process can be much simpler. Modern analytical instrumentation, like high performance liquid chromatography with versatile detectors such as the ultraviolet photodiode array spectrometer (HPLC-PDA), allow simplified procedures to be employed to verify that an analysis procedure accurately and consistently will deliver a reliable measurement of an active ingredient in a compounded preparation.

Of critical importance in these simplified procedures are:

  • Specificity: Can we measure the drug of interest without interference from the excipient matrix and from potential breakdown products? Judicious HPLC column selection, mobile phase choice, and the PDA detector are of paramount importance in this determination, and quickly can show if an analytical approach is acceptable.
  • Linearity, Precision, and Accuracy: Is the measure consistent over the range of interest (+/- 10% of the label concentration), and what accuracy can we expect for the measurement? These tests often can be completed in a combined series of limited measurements for the specific compounded drug preparation under study. US Pharmacopeia or other certified standards are used to establish the accuracy of the measurement.
  • Detection and quantitation limit can be determined for the measurement based on the information gathered from the proceeding tests.
  • Since the tests are to be performed at Eagle Analytical with a consistent set of instrumentation and analytical procedures, a detailed measurement of robustness usually is not performed.

In summary, analytical method development allows Eagle Analytical to confirm that an accurate and reliable potency measurement can be performed on your sample. 

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