Abstract
A new, simple, rapid, sensitive, accurate, and affordable spectrofluorimetric method was developed and validated for the estimation of ganciclovir in bulk as well as in marketed formulations. The method was based on measuring the native fluorescence of ganciclovir in 0.2 M hydrochloric acid buffer of pH 1.2 at 374 nm after excitation at 257 nm. The calibration graph was found to be rectilinear in the concentration range of 0.25–2.00 μg mL−1. The limit of quantification and limit of detection were found to be 0.029 μg mL−1and 0.010μg mL−1, respectively. The method was fully validated for various parameters according to ICH guidelines. The results demonstrated that the procedure is accurate, precise, and reproducible (relative standard deviation <2%) and can be successfully applied for the determination of ganciclovir in its commercial capsules with average percentage recovery of 101.31 ± 0.90.
Highlights
Ganciclovir, 9-[(1,3-dihydroxy-2-propoxy) methyl]guanine, is a well-known anti-viral agent
CMV infections are the main cause of morbidity and mortality in immunocompromised patients, mainly in those with the acquired immunodeficiency syndrome (AIDS), congenital immunodeficiency, or in individuals following organ transplantation [3]
Several high performance liquid chromatography (HPLC) and few radioimmunoassay and enzyme-linked immunosorbent assays have been reported for the quantification of this drug [4]
Summary
Ganciclovir, 9-[(1,3-dihydroxy-2-propoxy) methyl]guanine, is a well-known anti-viral agent. CMV infections are the main cause of morbidity and mortality in immunocompromised patients, mainly in those with the acquired immunodeficiency syndrome (AIDS), congenital immunodeficiency, or in individuals following organ transplantation [3] In these patients ganciclovir is one of the preferred drugs for treatment. Several high performance liquid chromatography (HPLC) and few radioimmunoassay and enzyme-linked immunosorbent assays have been reported for the quantification of this drug [4]. Most of these methods are developed to quantify ganciclovir in biological fluids like plasma, serum, and tissues [5,6,7,8,9,10,11,12]. The proposed method was fully validated according to ICH guidelines, and successfully applied for the determination of the drug in its capsules
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