Abstract
Two simple, selective and sensitive spectrophotometric methods were developed and validated for the determination of valganciclovir hydrochloride (VLGH) in pure drug and tablets. The first method was based on the reduction of iron(III) to iron(II) by VLGH and subsequent formation of iron(III)-ferricyanide complex (Prussian blue) in acid medium which was measured at 730 nm (method A). In the second method (method B), permanganate was reduced by VLGH to bluish green manganate in alkaline medium and the absorbance was measured at 610 nm. The absorbance measured in each case was related to VLGH concentration. The experimental conditions were carefully studied and optimized. Beer’s law was obeyed over the concentration ranges of 2.5-20.0 and 2.0-40.0 µg mL-1 for method A and method B, respectively, with corresponding molar absorptivity values of 1.28×104 and 6.88×103 L mol-1 cm-1. The limits of detection (LOD) and quantification (LOQ) were 0.11 and 0.33 µg mL-1 (method A) and 0.21 and 0.64 µg mL-1 (method B). Within-day and between-day relative standard deviations (%RSD) at three different concentrations levels were < 2.4%, and the respective relative errors (%RE) were ≤ 3%. The proposed methods were successfully applied to the determination of VLGH in tablets, and the results confirmed that the proposed methods were equally precise and accurate as the official method.
Highlights
Valganciclovir hydrochloride (VLGH) is the L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9yl) methoxy]-3-hydroxypropylester, monohydrochloride (Figure 1), the drug is soluble in water and methanol, insoluble in ether and it’s available as white crystals
2.0 mL) of 100 μg mL-1 standard VLGH solution were accurately transferred into a series of 10 mL calibrated flasks and the volume was brought to 2.0 mL with water
This process involved the reduction of iron(III) by VLGH and the resulting iron(II) reacted with ferricyanide forming intense, Prussian blue similar to previous reports which was measured at 730 nm (Figure 2)
Summary
Valganciclovir hydrochloride (VLGH) is the L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9yl) methoxy]-3-hydroxypropylester, monohydrochloride (Figure 1), the drug is soluble in water and methanol, insoluble in ether and it’s available as white crystals. VLGH is the L-valyl ester of, and product for ganciclovir (Sugawara et al, 2000). Cytomegalovirus infection in transplant recipients usually occurs when latent viruses from a seropositive donor organ are reactivated owing to immunosuppression (Koda-Kimble et al, 2009), due to this matter; numeral drugs were developed and used for cytomegalovirus (CMV) prophylaxis after organ transplants. The most widely used drugs for this case include VLGH, ganciclovir, and acyclovir. VLGH is a FDA approved medication for the prevention of CMV disease in certain transplant recipients at high risk for developing CMV diseases (AIDSinfo, 2016). Activation of ganciclovir requires at first conversion to ganciclovir monophosphate form by viral enzymes: protein kinase pUL97 in CMV (Charles, Robert, 2012)
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