Singh, Parul and Jangir, Deepak K. and Mehrotra, Ranjana and Bakhshi, A. K. (2009) Development and validation of an infrared spectroscopy-based method for the analysis of moisture content in 5-fluorouracil. Drug Testing and Analysis, 1 (6). pp. 275-278. ISSN 1942-7611

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Abstract

The determination of moisture content in pharmaceuticals is very important as moisture is mainly responsible for the degradation of drugs. Degraded drugs have reduced efficacy and could be hazardous. The objective of the present work is to replace the Karl Fischer (KF) titration method used for moisture analysis with a method that is rapid, involves no toxic materials and is more effective. Diffuse reflectance infrared (IR) spectroscopy, which is explored as a potential alternative to various approaches, is investigated for moisture analysis in 5-fluorouracil, an anticancer drug. A total of 150 samples with varying moisture content were prepared in laboratory by exposing the drug at different relative humidities, for different time intervals. Infrared spectra of these samples were collected with a Fourier transform infrared (FTIR) spectrophotometer using a diffuse reflectance accessory. Reference moisture values were obtained using the Karl Fischer titration method. A number of calibration models were developed using the partial least squares (PLS) regression method. A good correlation was obtained between predicted IR values and reference values in the calibration and validation set. The derived calibration curve was used to predict moisture content in unknown samples. The results show that IR spectroscopy can be used successfully for the determination of moisture content in the pharmaceutical industry.

Item Type:	Article
Additional Information:	Copyright for this article belongs to M/s John Wiley and Sons.
Uncontrolled Keywords:	diffuse reflectance; 5-fluorouracil; infrared spectroscopy; moisture content
Subjects:	Pharmacology & Pharmacy
Divisions:	UNSPECIFIED
Depositing User:	Ms Neetu Chandra
Date Deposited:	17 Aug 2012 08:59
Last Modified:	17 Aug 2012 08:59
URI:	http://npl.csircentral.net/id/eprint/440

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