AJAC  Vol.2 No.8 , December 2011
Comparison of FT-NIR Transmission and HPLC to Assay Montelukast in Its Pharmaceutical Tablets
Abstract: For several years, near-infrared spectroscopy (NIRS) has become an analytical technique of great interest for the pharmaceutical industry, particularly for the non-destructive analysis of dosage forms. The goal of this study is to show the capacity of this new technique to assay the active ingredient in low-dosage tablets. NIR spectroscopy is a rapid, non-destructive technique and does not need any sample preparation. A prediction model was built by using a partial least square regression fit method. The NIR assay was performed by transmission. The results obtained by NIR spectroscopy were compared with the conventional HPLC method for Montelukast tablets produced by Sigma pharmaceutical corp. The study showed that Montelukast tablets can be individually analyzed by NIR with high accuracy. It was shown that the variability of this new tech- nique is less important than that of the conventional method which is the HPLC with UV detection.
Cite this paper: nullA. Eldin and A. Shalaby, "Comparison of FT-NIR Transmission and HPLC to Assay Montelukast in Its Pharmaceutical Tablets," American Journal of Analytical Chemistry, Vol. 2 No. 8, 2011, pp. 885-891. doi: 10.4236/ajac.2011.28102.

[1]   FDA, “PAT—A Framework for Innovative Pharmaceu- tical Manufacturing and Quality Assurance,” 2004.

[2]   E. W. Ciurczak and J. K. Drennen, “Practical Spectros- copy Series: Pharmaceutical d Medical Applications of Near-Infrared Spectroscopy,” Marcel Dekker, New York, 2002.

[3]   W. Plugge and C. Van der Vlies, “The Use of Near In- frared Spectroscopy in the Quality Control Laboratory of the Pharmaceutical Industry,” Journal of Pharmaceutical and Biomedical Analysis, Vol. 10, No. 10-12, 1992, pp. 797-803. doi:10.1016/0731-7085(91)80083-L

[4]   C. I. Gerh¨ausser and K. A. Kovar, “Strategies for Constructing Near-Infrared Spectral Libraries for the Identification of Drug Substances,” Applied Spectroscopy, Vol. 51, No. 10, 1997, pp. 1504-1510. doi:10.1366/0003702971939000

[5]   M. J. Vredenbregt, P. W. J. Caspers, R. Hoogerbrugge and D. M. Barends, “Choice and Validation of a Near Infrared Spectroscopic Application for the Identity Control of Starting Materials.: Practical Experience with the EU Draft Note for Guidance on the Use of Near Infrared Spectroscopy by the Pharmaceutical Industry and the Data to be Forwarded in Part II of the Dossier for a Marketing Authorization,” European Journal of Pharmaceutics and Biopharmaceutics, Vol. 56, No. 3, 2003, pp. 489-499. doi:10.1016/S093

[6]   S. S. Sekulic, H. W. Ward and P. K. Aldridge, “On-Line Monitoring of Powder Blend Homogeneity by Near-In- frared Spectroscopy,” Analytical Chemistry, Vol. 68, No. 3, 1996, pp. 509-513. doi:10.1021/ac950964m

[7]   P. Merckle and K.-A. Kovar, “Assay of Effervescent Tablets by Near-Infrared Spectroscopy in Transmittance and Reflectance Mode: Acetylsalicylic Acid in Mono and Combination Formulations,” Journal of Pharmaceutical and Biomedical Analysis, Vol. 17, No. 3, 1998, pp. 365- 374. doi:10.1016/S0731-7085(97)00194-5

[8]   R. P. Cogdill, C. A. Anderson and J. K. Drennen, Phar- maceutical Technology, 2004, pp. 29-34.

[9]   J. Sun, Journal of Chemometrics, Vol. 11, 1997, pp. 525-532.

[10]   R. J. Barnes, M. S. Dhanoa and S. J. Lister, “Standard Normal Variate Transformation and De-trending of Near- Infrared Diffuse Reflectance Spectra,” Applied Spectros- copy, Vol. 43, No. 5, 1989, pp. 772-777. doi:10.1366/0003702894202201

[11]   T. Fearn, NIR News, Vol. 10, 1999, pp. 10-11.

[12]   ICH Q2B, International Conference on Harmonisation, Validation of Analytical Procedures, Methodology, 2002.

[13]   FDA, “Guidance for Industry: Validation of Analytical Procedures,” Food and Drug Administration, Rockville, 1997.

[14]   International Conference on Harmonisation Topic Q2B, “Validation of Analytical Methods: Methodology,” The Third International Conference on Harmonization of Technical Requirements for Registration of Pharmaceu- ticals for Human Use (ICH) Yokohama-Japan.

[15]   Y. V. Heyden, A. Nijhuis, J. Smeyers-Verbeke and B. G. M. Vandeginste D. L., Journal of Pharmaceutical and Biomedical Analysis, 2001, p. 24723.

[16]   A. Eustaquio, P. Graham, R. D. Jee, A. C. Moffat and A. D. Trafford, “Quantification of Paracetamol in Intact Tablets Using Near-Infrared Transmittance Spectros- copy,” Analyst, Vol. 123, No. 11, 1998, pp. 2303-2306. doi:10.1039/a804528c

[17]   R. Ragonese, M. Mulholland and J. Kalman, “Full and Fractionated Experimental Designs for Robustness Test- ing in the High-Performance Liquid Chromatographic Analysis of Codeine Phosphate, Pseudoephedrine Hy- drochloride and Chlorpheniramine Maleate in a Pharma- ceutical Preparation,” Journal of Chromatography A, Vol. 870, No. 1-2, 2000, p. 45. doi:10.1016/S0021-9673(99)00972-3

[18]   G. A. Lewis, D. Mathieu and R. Phan-Tan-Luu, “Phar- maceutical Experimental Design,” Marcel Dekker, New York, 1999.