Abstract
A simple, rapid and accurate High performance thin layer chromatography is described for the Development and validation of HPTLC method for Valganciclovir Hydrochloride in bulk and Pharmaceutical dosage form. The separation is carried out on Merck TLC aluminum sheets of silica gel 60 F254 using Chloroform: Methanol: Ammonia (6.5:3.4:0.1v/v) mobile phase. Quantification was done by Densitometric scanning at 254nm. The linearity was found to be the range of 100-500ng/spot for Valganciclovir hydrochloride with the correlation coefficient of 0.9993. The regression equation was found to be Y=10.168x-94.8. The Rf value of Valganciclovir hydrochloride was found to be 0.74. The LOD and LOQ were found to 9.19 and 27.87 respectively. Average recovery was found to be 99.66% which show that the method was free from interference from excipients present in the formulation. Simultaneously the Percentage relative standard deviation was well within the range of 2%. The above method was validated according to the ICH guidelines. The established method enabled accurate, precise and applied to the analysis of Valganciclovir hydrochloride in bulk and Pharmaceutical dosage form. Â
Highlights
Valganciclovir hydrochloride is a hydrochloride salt form of Valganciclovir, a prodrug form of ganciclovir, a nucleoside analogue of 2’deoxyguanosine, with antiviral activity
The present study describes a simple, precise and accurate analytical method for the estimation of Valganciclovir hydrochloride in bulk and pharmaceutical dosage forms
In order to determine the limit of detection (LOD) and limit of quantification (LOQ), Valganciclovir hydrochloride concentrations in the lower part of the linear range of the calibration curve were used
Summary
Valganciclovir hydrochloride is a hydrochloride salt form of Valganciclovir, a prodrug form of ganciclovir, a nucleoside analogue of 2’deoxyguanosine, with antiviral activity. Valganciclovir hydrochloride is an antiviral agent that is used to treat cytomegalovirus retinitis in patients with AIDS, and for the prevention of cytomegalovirus infections in organ transplant recipients who have received an organ from a CMV-positive donor. The Valganciclovir acts by slowing the growth of the CMV virus. It helps prevent the spread of infection to other areas of the body. Valganciclovir hydrochloride is available in the form of White to off crystalline powder. Valganciclovir hydrochloride is available under the brand name of Valcyte, Cymeral, Rovalcyte and Darilin. The present study describes a simple, precise and accurate analytical method for the estimation of Valganciclovir hydrochloride in bulk and pharmaceutical dosage forms. The above method was developed and validated according to the ICH guidelines
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