alexa Effect of Reconstitution Solvents and Containers on Kinetics and Safety of Cephradine Neutralized with L-Arginine
ISSN: 2157-7609

Journal of Drug Metabolism & Toxicology
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Research Article

Effect of Reconstitution Solvents and Containers on Kinetics and Safety of Cephradine Neutralized with L-Arginine

Aman Ullah Khan1, Javeid Iqbal1, Saif-ur-Rehman Khattak2* and Najam-us-Saquib1

1Faculty of Pharmacy, Hamdard University, Sharea Madinat Al-Hikmah, Muhammad Bin Qasim Avenue, Karachi-74600, Pakistan

2Central Drugs Laboratory, DRAP, Block-B, S.M.C.H.S Karachi, Pakistan

*Corresponding Author:
Saif-ur-Rehman Khattak
Central Drugs Laboratory
DRAP, Block-B, S.M.C.H.S Karachi, Pakistan
E-mail: [email protected]

Received Date: April 19, 2013; Accepted Date: May 22, 2013; Published Date: May 24, 2013

Citation: Khan AU, Iqbal J, Khattak SR, Saquib N (2013) Effect of Reconstitution Solvents and Containers on Kinetics and Safety of Cephradine Neutralized with L-Arginine. J Drug Metab Toxicol 4:150. doi: 10.4172/2157-7609.1000150

Copyright: © 2013 Khan AU, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abstract

The effect of reconstitution solvents such as water for injection, 0.5% metronidazole injection, 0.9% sodium chloride injection and 5% dextrose injection, has been investigated on the kinetics of degradation of cephradine neutralized with L-arginine contained in glass, polyvinylchloride (PVC) and polyethylene pthalate (PET) containers at 5, 15 and 30°C. The analytical method described in USP-31 for the analysis of cephradine injection was employed in this study after slight modification and validation in respect of specificity, linearity, accuracy and precision. The degradation of the compound showed first-order kinetics and the degradation rate constants ‘kobs’ were found in the range of 1.84-3.07 × 10-3 hr-1 (r2=0.990-0.999) at 5°C, 2.3-4.2 x 10-3 hr-1 (r2=0.993-0.999) at 15°C and 1.18-9.97 × 10-3 hr-1 (r2=0.998-0.999) at 30°C, respectively. The compound showed maximum stability in dextrose solution followed by water for injection, sodium chloride injection and metronidazole injection; however, linear effect of containers on degradation rate could not be established. The extended degradation did not change the kinetics of the reaction. The abnormal toxicity/ safety test on mice for the admixtures in different containers at various temperatures showed no abnormal toxicity

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