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, \(\Delta E_{{\text{ab}}}^ * \) (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 \(\Delta E_{{\text{ab}}}^ * \) and ΔYI are found to be reliable indicators of discoloration. The tolerance limits proposed in terms of \(/Delta E_{{\text{ab}}}^ * \) 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.
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Abbreviations
- EMEA:
-
European Agency for the Evaluation of Medicinal Products
- CIE:
-
Commission Internationale de l’Eclairage
- CD:
-
Cefdinir
- CX:
-
Cefixime
- CU:
-
Cefuroxime axetil
- CP:
-
Cefpodoxime proxetil
- NFX:
-
Norfloxacin
- GFX:
-
Gatifloxacin
- SPX:
-
Sparfloxacin
- DIN:
-
Official German Standard Color System
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Acknowledgements
The authors thank (a) the Head, Department of Chemistry, Rashtrasant Tukadoji Maharaj Nagpur University for providing laboratory and gamma irradiation facilities, (b) the Board of Radiation and Isotope Research, Bhabha Atomic Research Centre, Vashi, Mumbai for providing e-beam-irradiation facility. One of the authors Ms. Babita Singh would like to thank Central Forensic Science Laboratory, Directorate of Forensic Science, Ministry of Home Affairs, Hyderabad for providing her fellowship.
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Singh, B., Parwate, D.V. & Shukla, S.K. Radiosterilization of Fluoroquinolones and Cephalosporins: Assessment of Radiation Damage on Antibiotics by Changes in Optical Property and Colorimetric Parameters. AAPS PharmSciTech 10, 34–43 (2009). https://doi.org/10.1208/s12249-008-9177-y
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DOI: https://doi.org/10.1208/s12249-008-9177-y