Cleaning Verification: Method Development and Validation Using Ion Mobility Spectrometry - Pharmaceutical Technology

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Cleaning Verification: Method Development and Validation Using Ion Mobility Spectrometry
The authors discuss the theory of ion mobility spectrometry, its benefit over HPLC analysis in cleaning verification, and the experimental considerations for method validation and validation.


Pharmaceutical Technology
Volume 33, Issue 7, pp. 60-63




IMS distinguishes ions of a given compound on the basis of their velocities through a drift tube under the influence of a weak electric field. Ion velocity (v) is proportional to the applied electric field (E)




in which K is the ion mobility in units of cm2 /Vs. Drift time t is proportional to 1/K , ion mass m, and collisional cross section C.




Reduced mobility K o for an analyte is calculated by normalizing its drift time to that of the internal calibrant as in the following equation:

in which (K o C ) is the reduced mobility of the calibrant and t C is the drift time of the calibrant.


Figure 3: Illustration of ions of varying sizes migrating toward the detector through a constant flow of air.
These velocities, or ion mobilities, are determined and selective for a given compound. The high sensitivity of the instrument (nanogram to picogram range) provides for an excellent technique to quickly verify equipment cleanliness. Figure 3 illustrates the separation process described in the theory above. This technique allows for positive or negative mode of detection. Each mode has a unique internal calibrant used for calculation of the K o . In the positive mode the internal calibrant is nicotinamide. In the negative mode the internal calibrant is methyl salicylate.


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