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Albuterol (or albuterol sulfate) is

used for the treatment of asthma.
It's generally taken as either
tablets or from an
inhaler. WCAS provides testing
for albuterol according to USP
monographs as well as in
inhalers.

There are at least two methods

for determining the dose of
Albuterol from an inhaler, an
HPLC method based upon the
USP monograph for the API or
LC-MS. USP sets standards for
albuterol tablets but not inhalers.
The method for assaying tablets
is based on reverse phase HPLC 4
  
with an ion pair reagent with
detection using UV absorbance at
276 nm. For legal cases, we
prefer the following method
using LC-MS because it provides
definitive identification of the
albuterol active ingredient as
well as the dose assay.


 resolves it well from the ipratropium


 bromide also present in the inhaler. Identity
We have developed a method for
confirmation of Albuterol in
Inhalation Solutions. This
method uses LC-MS with
electrospray ionization. With a
relatively high capillary voltage,
some fragmentation is induced to
give a representative spectrum.
The chromatographic conditions
use a mixed mode LC column.
This gives good peak shape for
is then confirmed by both retention time and
mass spectral match. Quantitation is
performed using external standards to
confirm the dosage level, although not to the
degree of precision required by USP testing
for the API.
A representative LC-MS chromatogram and
mass spectrum are shown below.
4
  
the albuterol and


 Example Report:

First, the samples are prepared Micrograms/Actuation

by removing the canisters from as Albuterol
the mouthpiece and dispensing Sample as Albuterol Sulfate
five actuations from each
sample into water containing Control 100 120
salicyl alcohol as an internal Sample 115 138
standard. An aliquot of the Sample
water is then evaporated to Duplicate 103 124
dryness and the TMS Detection
derivatizing agent is added to Limit 4 5
the residue. The solutions are
then analyzed by GCMS.
Quantitation is performed using Weight Weight grams
actuations before after lost per
the internal standard method
against a five-point initial Sample taken (g) (g) actuation
calibration. Additionally, one Control 5 28.2366 27.8609 0.0751
sample is prepared in duplicate. Sample 10 28.4295 27.5794 0.0850
Results are given as free
albuterol and albuterol sulfate
per actuation from the valve.