Article citationsMore>>

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

has been cited by the following article:

• TITLE: Comparison of FT-NIR Transmission and HPLC to Assay Montelukast in Its Pharmaceutical Tablets

  AUTHORS: Ahmed B. Eldin, Abdalla A. Shalaby

  KEYWORDS: FT-NIR Transmission, PAT, Validation, HPLC Assay, Montelukast Tablets, PLS Model

  JOURNAL NAME: American Journal of Analytical Chemistry, Vol.2 No.8, December 7, 2011

  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.