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AAPS PharmSciTech. 2009 March; 10(1): 34–43.
Published online 2009 January 15. doi:  10.1208/s12249-008-9177-y
PMCID: PMC2663667
Radiosterilization of Fluoroquinolones and Cephalosporins: Assessment of Radiation Damage on Antibiotics by Changes in Optical Property and Colorimetric Parameters
Babita Singh,corresponding author1,2 D. V. Parwate,1 and S. K. Shukla2
1Department of Chemistry, RTM Nagpur University, Nagpur University Campus, Amravati Road, Nagpur, India 440033
2Central Forensic Science Laboratory, Ramanthapur, Hyderabad, India 500013
Babita Singh, Phone: +91-9890099272, singhbab2001/at/rediffmail.com.
corresponding authorCorresponding author.
Received June 28, 2008; Accepted November 26, 2008.
Abstract
A most common problem encountered in radiosterilization of solid drugs is discoloration or yellowing. By pharmacopoeia method, discoloration can be assessed by measuring absorbance of solutions of irradiated solid samples at 450 nm. We propose to evaluate discoloration of solid samples directly by recording their diffuse reflectance spectra. Further, the reflectance spectrum is used to compute various color parameters: CIE XYZ tristimulus value, CIE Lab, equation M1 (color difference), yellowness index (YI), dominant wavelength, and excitation purity by CIE method. The investigation of difference reflectance spectra and color parameters revealed that for fluoroquinolones, e-beam was more damaging than gamma radiation, whereas for cephalosporins, trend was reversed. The quantum of discoloration with gamma radiation and e-beam is found to be nearly equal when assessed by pharmacopeia method, and it is therefore inadequate to assess small color differences. The color parameters equation M2 and ΔYI are found to be reliable indicators of discoloration. The tolerance limits proposed in terms of equation M3 and ΔYI are ±2 and ±10 U, respectively. The dominant wavelength for all compounds has shifted to higher values indicating change in hue but defining color tolerance limit with this parameter requires adjunct excitation purity value.
Key words: cephalosporin, color difference, fluoroquinolone, radiosterilization, yellowness index
Articles from AAPS PharmSciTech are provided here courtesy of
American Association of Pharmaceutical Scientists