Non-invasive determination of ethanol, propylene glycol and water in a multi-component pharmaceutical oral liquid by direct measurement through amber plastic bottles using Fourier transform near-infrared spectroscopy.
2000
Fourier transform near-infrared (FT-NIR) spectroscopy was used
to quantify rapidly the ethanol (34–49% v/v), propylene glycol
(20–35% v/v) and water (11–20% m/m) contents within a
multi-component pharmaceutical oral liquid by measurement directly through
the amber plastic bottle packaging. Spectra were collected in the range
7302–12000 cm−1 and calibration models set-up using
partial least-squares regression (PLSR) and multiple linear regression.
Reference values for the three components were measured using capillary gas
chromatography (ethanol and propylene glycol) and Karl Fischer (water)
assay procedures. The calibration and test sets consisted of production as
well as laboratory batches that were made to extend the concentration
ranges beyond the natural production variation. The PLSR models developed
gave standard errors of prediction (SEP) of 1.1% v/v for ethanol, 0.9% v/v
for propylene glycol and 0.3% m/m for water. For each component the
calibration model was validated in terms of: linearity, repeatability,
intermediate precision and robustness. All the methods produced
statistically favourable outcomes. Ten production batches independent of
the calibration and test sets were also challenged against the PLSR models,
giving SEP values of 1.3% v/v (ethanol), 1.0% v/v (propylene glycol) and
0.2% m/m (water). NIR transmission spectroscopy allowed all three liquid
constituents to be non-invasively measured in under 1 min.
Keywords:
- Correction
- Source
- Cite
- Save
- Machine Reading By IdeaReader
7
References
42
Citations
NaN
KQI