Ganciclovir functions as an antiviral medication crucial for
averting cytomegalovirus disease among recipients of bone marrow and solid
organ transplants. Furthermore, it plays a pivotal role in managing individuals
with compromised immune systems by combatting viral infections effectively.
This study aims to develop and validate a simple, rapid and sensitive
redox-based spectrophotometric method for the quantification of Ganciclovir in
pure and pharmaceutical dosage forms. The development process involved
utilizing 0.1 M HCl as the solvent along with a combination of ferric chloride
and 1,10-phenanthroline as the chromogenic reagent.
After development, the method underwent optimization across
various conditions to ensure its efficacy, followed by rigorous statistical
validation. Based on the optimization studies, it was determined that the
optimal composition for the method included a mixture containing 0.3% w/v of
ferric chloride and 0.5% w/v of 1,10-phenanthroline, with a drug-to-reagent
mole ratio of 0.5:0.5. When measured at 510.0 nm, the method exhibited
linearity within the concentration range of 5.0-30.0 μg/mL for Ganciclovir. Demonstrating
its sensitivity, the method showcased a low limit of detection and
quantification values, recorded at 0.30 and 0.90 μg/mL, respectively. The
validation parameters of the method were found to align with the standards
outlined by the ICH guidelines. With a % assay value of 99.2, the method
demonstrated its suitability for pharmaceutical formulation analysis. The
simplicity of the developed method renders it suitable for application in
quality control testing of Ganciclovir within formulations.
Author(s) Details:
Dr. Naraparaju
Swathi, M. Pharm., Ph.D.
Department of Pharmaceutical Chemistry, Gokaraju Rangaraju College of
Pharmacy, Hyderabad-500090, Telangana, India.
Mrs. Barla Karuna
Devi, M. Pharm. (Ph.D.)
Department of Pharmaceutical Chemistry, Gokaraju Rangaraju College of
Pharmacy, Hyderabad-500090, Telangana, India.
Dr. Anumolu Durga
Pani Kumar
Department of Pharmaceutical Analysis, Gokaraju Rangaraju College of
Pharmacy, Hyderabad-500090, Telangana, India.
Please see the book here:
https://doi.org/10.9734/bpi/prrat/v1/196
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