APPLICATION OF FOURIER TRANSFORM INFRARED  SPECTROSCOPY FOR QUALITY CONTROL OF PHARMACEUTICAL  PRODUCTS: A REVIEW

Abdul Rahman

doi:10.14499/indonesianjpharm23iss1pp1-8

APPLICATION OF FOURIER TRANSFORM INFRARED SPECTROSCOPY FOR QUALITY CONTROL OF PHARMACEUTICAL PRODUCTS: A REVIEW

Abdul Rahman

Abstract

Analysis of pharmaceutical products covers all aspects of quality control of active pharmaceutical ingredients (API) and finished products. Today, Fourier transform infrared (FTIR)

spectroscopy, especially in combination with chemometrics software, has emerged as one of the romising analytical techniques to be used in pharmaceutical industry, for quality control of desired pharmaceutical products. Compared with other instrumental techniques, FTIR spectroscopy offers some advantages, namely it is rapid, simple in sample preparation, and not destructive. In this review, the application of FTIR spectroscopy for qualitative and quantitative determinations of API and monitoring drug release are described.

Key words: FTIR spectroscopy, quality control, pharmaceutical products.

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References

Aaltonen, J., Keith C. ordon, K.C., Strachan, C.J., and Rades, T. 2008. Review: Perspectives in the use of spectroscopy to characterise pharmaceutical solids. Int. J. Pharm. 364: 159–169.

Bertacche, V., Pini, E., Stradi, R., and Stratta, F. 2006. Quantitative determination of amorphous cyclosporine in crystalline cyclosporine samples by Fourier transform infrared spectroscopy. J. Pharm. Sci.96(1): 159 – 166.

Blanco, M. and Peguero, A. 2010. Analysis of pharmaceuticals by NIR spectroscopy without a reference method. Trends Anal. Chem. 29: 1127-1136.

Boiret, M., Meunier, L. and Ginot, Y-M. 2011. Tablet potency of tianeptine in coated tablets by near infrared spectroscopy: model optimization, calibration transfer and confidence intervals. J. Pham. Biomed Anal.54: 510 – 516.

Boyer, C., Bregere, B., Crouchet, S., Gaudin, K., and Dubost, J.P. 2006. Direct determination of niflumic acid in a pharmaceutical gel by ATR/FTIR spectroscopy and PLS calibration. J. Pham. Biomed Anal.40: 433 – 437.

Brereton, R.G. 2007. Applied Chemometrics for Scientist. 1st Edition, John Wiley & Sons, Ltd., Chichester, UK.

Carolei, L. and Gutz, I.G.R. 2005. Simultaneous determination of three surfactants and water in shampoo and liquid soap by ATR-FTIR. Talanta 66: 118–124.

Che Man, Y.B., Syahariza, Z.A., and Rohman, A. 2010. Chapter 1. Fourier transform infrared (FTIR) spectroscopy: development, techniques, and application in the analyses of fats and oils, in Fourier Transform Infrared Spectroscopy edited by Oliver J. Ress, Nova Science Publishers, New York: USA. 1 – 26.

Crupi, V., Majolino, D., Mondello, M.R., Migliardo, P. And Venuti, v. 2002. FTIR spectroscopy: a powerful tool in pharmacology. J. Pham. Biomed. Anal.29: 1149 - 1152.

de la Guardia, M. 2010. Green analytical chemistry. Trends Anal. Chem.29: 577.

Der Weerd, J.V. and Kazarian, S.G. 2005. Release of poorly soluble drugs from HPMC tablets studied by FTIR imaging and flow-through dissolution tests. J. Pharm. Sci.94: 2096–2109.

Dijiba, Y.K., Zhang, A., Niemczyk, T.M. 2005. Determinations of ephedrine in mixtures of ephedrine and pseudoephedrine using diffuse reflectance infrared spectroscopy. Int. J. Pharm.289: 39–49.

Févotte, G. Calas, J., Puel, F. and Hoff, C. 2004. Applications of NIR spectroscopy to monitoring and analyzing the solid state during industrial crystallization processes. Int. J. Pharm.273: 159–169.

Gallardo-Velázquez, T., Osorio-Revilla, G., Zuñiga-de Loa, M. and Rivera-Espinoza, Y. 2009. Application of FTIR-HATR spectroscopy and multivariate analysis to the quantification of adulterants in Mexican honeys. Food Res. Int. 42: 313–318.

Hanh, B.D., Neubert, R.H.H., and Wartewig, S. 2000a. Investigation of drug release from suspension using FTIR-ATR technique: part I. Determination of effective diffusion coefficient of drugs. Int. J.

Pharm.204: 145–150.

Hanh, B.D., Neubert, R.H.H., and Wartewig, S. 2000b. Investigation of drug release from suspension using FTIR-ATR technique: part II. Determination of dissolution coefficient of drugs. Int. J. Pharm. 204: 151–158.

Hu, Y., Erxleben, A., Ryder, A.G., and McArdle, P. 2010. Quantitative analysis of sulfathiazole polymorphs in ternary mixtures by attenuated total reflectance infrared, near-infrared and Raman spectroscopy. J. Pharm. Biomed. Anal. 53: 412–420.

Lutker, K.M., Qui˜nones, R., Xu, J., Ramamoorthy, A., and Matzger, A.J. 2011. Polymorphs and Hydrates of Acyclovir. J. Pharm. Sci. 100(3): 949 – 963.

Kachrimanis, K., Rontogianni, M. and Malamataris, S. 2010. Simultaneous quantitative analysis of mebendazole polymorphs A–C in powder mixtures by DRIFTS spectroscopy and ANN modeling. J. Pharm. Bio.. Anal.51: 512–520.

Khanmohammadi, M., Mobedi, H., Mobedi, E., Kargosha, K., Garmarudi, A.B., and Ghasemi, K. (2009) Quantitative determination of naltrexone by attenuated total reflectance—FTIR spectrometry using partial least squares (PLS) wave ength selection. Spectroscopy 23: =113–121.

Khanmohammadi, M., Mobedi, E., Garmarudi, A.B., Mobedi, H., and Kargosha, K. 2007. Simultaneous determination of levodopa and carbidopa in levodopacarbidopa tablets by ATR-FTIR spectrometry. Pharmaceut. Dev. Tech. 12: 573–580.

Karabas, I., Orkoula, M.G., and Kontoyannis, C.G. 2007. Analysis and stability of polymorphs in tablets: The case of risperidone. Talanta 71: 1382–1386.

Karamancheva, I. and Staneva, T. 2000. Determination of possible impurities in piracetam using FTIR spectroscopy. J. Pharm. Biomed. Anal.21: 1161–1169.

Kassis, A., Bhawtankar, V.M. and Sowa Jr, J.R. 2010. Attenuated total reflection infrared spectroscopy (ATR-IR) as in situ technique for dissolution studies. J. Pham. Biomed. Anal.53: 269-273.

Lukitaningsih, E., Saadah, M., Purwanto, and Rohman, A.. 2012. Quantitative analysis of lard in lotion cosmetics formulation using FTIR spectroscopy and partial least square calibration. J. Am. Oil Chem. Soc.DOI. 10.1007/s11746-012-2052-8.

Massart, D.L. and Buydens, L.1988. Chemometrics in pharmaceutical analyis. J. Pham. Biomed. Anal. 6: 535 – 545.

Matkovic, S.R., Valle, G.M., and Briand, L.E. 2005. Quantitative analysis of ibuprofen in pharmaceutical formulations through FTIR spectroscopy. Latin Am. Appl. Res. 35: 189 – 195.

Mazurek, S. and Szostak, R. 2011. Comparison of infrared attenuated total reflection and Raman spectroscopy in the quantitative analysis of diclofenac sodium in tablets. Vib. Spectros. 57: 157–162.

McAuley, W.J., Mader, K.T., Tetteh, J., Lane, M.E., Hadgraft, J. 2009. Simultaneous monitoring of drug and solvent diffusion across a model membrane using ATRFTIR spectroscopy. Eur. J. Pharm. Sci. 38: 378 – 383.

Miller, J.N. and Miller, J.C. 2005. Statistics and chemometrics for analytical chemistry. 5th ed. Pearson Education Limited, Edinburgh Gate Harlow, England. pp. 213 – 239.

Moros, J., Garrigues, S., de la Guardia, M. 2010. Vibrational spectroscopy provides a green tool for multi-componnet analysis. Trends Anal. Chem. 29: 578 – 591.

Moros, J., Salvador arrigues, S. and de la Guardia, M. 2007. Quality control Fourier transform infrared determination of diazepam in pharmaceuticals. J. Pham. Biomed Anal. 43: 1277–1282.

Müller, M. and Keßler B. 2012. Release of pamidronate from poly(ethyleneimine)/cellulose sulphate complex nanoparticle films: An in situ ATR-FTIR study. J. Pharm. Biomed. Anal.http://dx.doi.org/ 10.1016/j.jpba.2012.03.047.

Peepliwal, A., Vyawahare, S.D. and Bonde, C.G. 2010. A quantitative analysis of Zidovudine containing formulation by FT-IR and UV. Food Anal. Methods. 2: 1756-1763.

P¨ oll¨ anen, K., H¨ akkinen, A., Huhtanen, M., Reinikainen, S.-P., Karjalainen, M., Rantanen, J., Louhi-Kultanen, M., and Nystr¨ om, L. 2005. DRIFT-IR for quantitative characterization of polymorphic composition of sulfathiazole. Anal. Chim. Acta 544: 108–117.

Ramos, M.L., Tyson, J.F. and Curran, D.J. 1998. Determination of acetaminophen by floow injection with on-line chemical derivatiza-tion: Investigations using visible and FTIR spectrophotometry. Anal. Chim. Acta364: 107 – 116.

Reinl, H.M., Hartinger, A., Dettmar, P., Bayerl, T.M., 1995. Time resolved infrared ATR measurements of liposome transport kinetics in human keratinocyte cultures and skin reveals a drastic dependence on liposome size and phase state. J. Invest. Deratol.105: 291–295.

Roggo, Y., Chalus, P., Maurer, L., LemaMartinez, C., Edmond, A. and Jent, N. 2007. A Review of near infrared spectroscopy and chemometrics in pharmaceutical technologies. J. Pham. Biomed Anal.44: 683 – 700.

Rohman, A. and Che Man. Y.B. 2011. Analysis of Lard in Cream Cosmetics Formulations using FT-IR Spectroscopy and Chemometrics. Middle-East J. Sci. Res. 7 (5): 726-732.

Rohman, A., Che Man, Y.B. and Sismindari. 2009. Quantitative analysis of virgin coconut oil (VCO) in cream cosmetics preparations using Fourier Transform Infrared (FTIR) spectroscopy. Pak. J. Pharm. Sci. 22(4): 415-420.

Rohman, A. and Che Man, Y.B. 2009. Analysis of water content in soap formulation using Fourier transform infrared (FTIR) spectroscopy. J. Appl. Sci. Res.5(7): 717-721

Rutan, S.C. 1992. Discovering chemistry with chemometrics. Chem. Intel. Lab. Systems 15: 137-141.

Salari, A. and Young, R.E. 1998. Application of attenuated total reflectance FTIR spectroscopy to the analysis of mixtures of pharmaceutical polymorphs. Int. J. Pharm. 163: 157–166.

Sherazi, S.T.H., Ali, M., and Mahesar, S.A. 2011. Application of Fourier-transform infrared (FT-IR) transmission spectroscopy for the estimation of roxithromycin in pharmaceutical formulations. Vib. Spectros. 55: 115–118.

Silva, F.E.B., Ferr˜ ao, M.F., Parisotto, G., M¨ uller, E.I., and Flores, E.M.M. 2009. Simultaneous determination of sulphamethoxazole and trimethoprim in powder mixtures by attenuated total

reflection-Fourier transform infrared and multivariate calibration. J. Pharm. Biomed. Anal. 49: 800–805.

Smith, B.C. 2002. Quantitative spectroscopy: Theory and Practice, Academic Press, Amsterdam, Holland. pp. 125 – 179.

Szakonyi G. and Zelkó, R. 2012. Water content determination of superdisintegrants by means of ATR-FTIR spectroscopy. J. Pham. Biomed Anal. 63: 106– 111.

Torrado, G., Garcia-Arieta, A., de los Rios, F., Menendez, J.C., and Torrado, S. 1999. Quantitative determination of dimethicone in commercial tablets and capsules by Fourier transform infrared

spectroscopy. J. Pham. Biomed Anal. 19, 285 – 291.

Vogt, F.G., Cohen, D.E., Bowman, J.D., Spoors, G.P., Zuber, G.E., Trescher, G.A., Dell’Orco, P.C., Katrincic, L.M., Debrosse, C.W., and Haltiwanger, R.C. 2005. Structural analysis of polymerphism and solvation in tranilast. J. Pharm. Sci.94: 651–665.

DOI: http://dx.doi.org/10.14499/indonesianjpharm23iss1pp1-8