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KMID : 0370220050490010001
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Yakhak Hoeji
2005 Volume.49 No. 1 p.1 ~ p.5
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Quantification of Naproxen in Pharmaceutical Formulation using Near-Infrared Spectrometry
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김도형/Kim DH
우영아/김효진/Woo YA/Kim HJ
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Abstract
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Near-infrared (NIR) spectroscopy has been widely applied in various field, since it is nondestructive and no sample preparation is required. In this paper, NIR spectroscopy was used for the determination of naproxen in a commercial pharmaceutical preparation. NIR spectroscopy was used to determine the content of naproxen in intact naproxen tablets containing 250 mg (65.8% nominal concentration) by collecting NIR spectra in the range of 1100~1750 nm. The laboratory-made samples had 46.1-85.5% nominal naproxen concentration. The measurements were made by reflection using a fiberoptic probe and calibration was carried out by partial least square regression (PLSR). Model validation was performed by randomly splitting the data set into calibration and validation data set (63 samples as a calibration data set and 42 samples as a validation data set). The developed NIR calibration gave results comparable to the known values of tablets in a laboratorial manufActuring process with standard error of calibration (SEC) and standard error of prediction (SEP) of 1.06% and 1.04%, respectively. The NIR method showed good accuracy and repeatability. NIR spectroscopic determination in intact tablets allowed the potential use of real time monitoring for a running production process.
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