Journal of the Serbian Chemical Society 2001 Volume 66, Issue 3, Pages: 189-198
https://doi.org/10.2298/JSC0103189N
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The application of near infrared reflectance spectroscopy (NIRS) for the quantitative analysis of hydrocortisone in primary materials
Nikolich K. (Medochemie Ltd, Limassol, Cyprus)
Sergides C. (Medochemie Ltd, Limassol, Cyprus)
Pittas A. (Medochemie Ltd, Limassol, Cyprus)
Near Infrared Reflectance Spectroscopy (NIRS), coupled with fiber optic
probes, has been shown to be a quick and reliable analytical tool for
quality assurance and quality control in the pharmaceutical industry, both
for verifications of raw materials and quantification of the active
ingredients in final products. In this paper, a typical pharmaceutical
product, hydrocortisone sodium succinate, is used as an example for the
application of NIR spectroscopy for quality control. In order to develop an
NIRS method with higher precision and accuracy than the official UV/VIS
spectroscopic method (BP '99), 19 samples, taken from one year’s production
and several prepared in the laboratory, having a hydrocortisone sodium
succinate concentration in the range from 89.05%to 95.83 %, were analysed by
NIR and UV/VIS spectroscopy. Three frequency ranges: 5939.73-5627.32 cm-1;
4863.64 - 4574.36 cm-1; 4308.23-4200.24 cm-1, with the best positive
correlation between the changes in the spectral and concentration data, were
chosen. The validity of the developed NIRS chemometric method for the
determination of the hydrocortisone sodium succinate concentration,
constructed by the partial least squares (PLS) regression technique, is
discussed. A correlation coefficient of 0.9758 and a standard error of cross
validation (RMSECV)of 1.06%were found between theUV/VISand
theNIRspectroscopic results of the hydrocortisone sodium succinate
concentration in the samples.
Keywords: FTNIRS, quantitative analysis, hydrocortisone