Quantification of paracetamol in intact tablets using near-infrared transmittance spectroscopy

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Alba Eustaquio, Paul Graham, Roger D. Jee, Anthony C. Moffatt and Andrew D. Trafford


Abstract

Production batch samples of paracetamol tablets and specially prepared out-of-specification batches covering the range 90–110% of the stated amount (500 mg) were analysed by the BP official UV assay and by NIR transmittance spectroscopy. NIR measurements were made on 20 intact tablets from each batch, scanned five times each (10 min measurement time per batch) over the spectral range 6000–11520 cm1. An average spectrum was calculated for each batch. Partial least squares (PLS) regression models were set up using a calibration set (20 batches) between the NIR response and the reference tablet paracetamol content (UV). Various pre-treatments of the spectra were examined; the smallest relative standard error of prediction (0.73%) was obtained using the first derivative of the absorbance over the full spectrum. Only two principal components were required for the PLS model to give a good relationship between the spectral information and paracetamol content. Applying this model to the validation set (15 batches) gave a mean bias of –0.08% and a mean accuracy of 0.59% with relative standard deviations of 0.75 and 0.44%, respectively. The proposed method is non-destructive and therefore lends itself to on-line/at-line production control purposes. The method is easy to use and does not require a knowledge of the mass of the tablets.


References

  1. B. G. Osborne, T. Fearn and P. H. Hindle, Practical NIR Spectroscopy with Applications in Food and Beverage Analysis, Longman, Harlow, 1986 Search PubMed.
  2. M. Blanco, J. Coello, H. Iturriaga, S. Maspoch and E. Bertran, Analyst, 1994, 119, 1779 RSC.
  3. K. A. Bunding Lee, Appl. Spectrosc. Rev., 1993, 28, 231 Search PubMed.
  4. J. K. Drennen and R. A. Lodder, in Advances in Near-Infrared Measurements, ed. G. Patonay, Jai Press, Greenwich, CT, 1993, vol. 1, pp. 93–112 Search PubMed.
  5. S. Sherken, J. Assoc. Off. Anal. Chem., 1968, 51, 616 Search PubMed.
  6. J. D. Kirsch and J. K. Drennen, Appl. Spectrosc. Rev., 1995, 30, 139 Search PubMed.
  7. R. A. Lodder, M. Selby and G. M. Hieftje, Anal. Chem., 1987, 59, 1921 CrossRef CAS.
  8. P. R. Khan, R. D. Jee, R. A. Watt and A. C. Moffat, Pharm. Sci., 1997, 3, 447 CAS.
  9. R. A. Lodder and G. M. Hieftje, Appl. Spectrosc., 1988, 42, 556 CAS.
  10. J. Gottfries, H. Depui, M. Fransson, M. Jongeneelen, M. Josefson, F. W. Langkilde and D. T. Witte, J. Pharm. Biomed. Anal., 1996, 14, 1495 CrossRef CAS.
  11. I. A. Cowe and J. W. McNichol, Appl. Spectrosc., 1985, 39, 257 CAS.
  12. M. A. Sharaf, D. L. Illman and B. R. Kowalski, Chemometrics, Wiley, New York, 1986 Search PubMed.
  13. British Pharmacopoeia 1993, HM Stationery Office, London, 1993, vol. II, p. 1043 Search PubMed.
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