Published:Journal of Chromatographic Science,
ISSN 0021-9665 Volume
45, Number 6, July 2007, pp.319-324
Stress Studies on Acyclovir
V.R. Sinha[1], Monika[1], A. Trehan[1], Manoj
Kumar[1], S. Singh[2], and J.R. Bhinge[1,3]
[1]University Institute of Pharmaceutical Sciences, Panjab University,
Chandigarh, India;
[2]Department of Pharmaceutics, Faculty of
Engineering, BHU, Varanasi, India; and
[3]Center with Potential for Excellence in Biomedical Sciences,
Panjab University, Chandigarh, India
Acyclovir is an antiviral drug of choice in the
treatment of many types of herpes virus infections, including
genital herpes simplex infections, herpetic conjunctivitis, herpes
simplex encephalitis, etc. The present study describes the degradation
behavior of acyclovir under different International Conference
on Harmonization recommended stress conditions (hydrolysis, oxidation,
photolysis, and thermal decomposition) in order to establish a
validated stability-indicating high-performance liquid chromatography
method. Acyclovir is found to degrade extensively in acidic conditions
and oxidative stress. Mild degradation of the drug occurs in alkaline
and neutral conditions. The drug is stable to dry heat. The drug
is found to be sufficiently stable after light exposure in a solid
state; however, photolytic degradation is observed when the drug
is exposed as a solution in water. The major degradation product
in acidic hydrolysis and photolysis is identified as guanine through
comparison with the standard. Separation of drug and the degradation
products under various conditions is successfully achieved on
a C-18 column utilizing water–methanol in the ratio of 90:10.
The flow rate is 1 mL/min, and the detection wavelength is 252
nm. The method is validated with respect to linearity, precision,
accuracy, selectivity, specificity, and robustness. The mean values
of slope and correlation coefficient are 39.307 and 0.9998 with
relative standard deviation values less than 2%. The recovery
of the drug is found to be in the range of 97.34% to 102.35%.
From the previous study it is concluded that the stabilityindicating
method developed for acyclovir can be used for analysis of the
drug in various stability samples.
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