Near‐Infrared and Fourier Transform Infrared Chemometric Methods for the Quantification of Crystalline Tacrolimus from Sustained‐Release Amorphous Solid Dispersion. Issue 8 (13th June 2014)

• Record Type: Journal Article
• Authors: Rahman, Ziyaur; Siddiqui, Akhtar; Bykadi, Srikant; Khan, Mansoor A.
• Is Part Of: Journal of pharmaceutical sciences. Volume 103:Issue 8(2014:Aug.)
• Page Start: 2376
• Page End: 2385
• Publication Date: 2014-06-13
• Subjects: Pharmacy -- Periodicals; 615.1
• DOI: 10.1002/jps.24055
• Languages: English
• ISSNs: 0022-3549

Abstract

<abstract abstract-type="main"> <title> <x xml:space="preserve">Abstract</x> </title> <p>The objective of the present research was to study the feasibility of using near‐infrared (NIR) and Fourier transform infrared (FTIR)‐based chemometric models in quantifying crystalline and amorphous tacrolimus from its sustained‐release amorphous solid dispersion (ASD). ASD contained ethyl cellulose, hydroxypropyl methyl cellulose, and lactose monohydrate as carriers, and amorphous form of tacrolimus in it was confirmed by X‐ray powder diffraction. Crystalline physical mixture was mixed with ASD in various proportions to prepare sample matrices containing 0%–100% amorphous/crystalline tacrolimus. NIR and FTIR of the samples were recorded, and data were mathematically pretreated using multiple scattering correction, standard normal variate, or Savitzky–Golay before multivariate analysis, partial‐least‐square regression (PLSR), and principle component regression (PCR). The PLSR models were more accurate than PCR for NIR and FTIR data as indicated by low value of root‐mean‐squared error of prediction, standard error of prediction and bias, and high value of <italic>R</italic><sup>2</sup>. Additionally, NIR data‐based models were more accurate and precise than FTIR data models. In conclusion, NIR chemometric models provide simple and fast method to quantitate crystalline tacrolimus in the ASD formulation. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 103:2376–2385, 2014</p> </abstract>