Abstract
DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHOD FOR ESTIMATION OF VALACYCLOVIR HYDROCHLORIDE IN TABLET DOSAGE FORM

Pankaj G. Sonar*, Sachin C. Khasawad, Neha P. Wagh, Yash G. Patil, Mahesh R. Patil, and Aishwarya R. Shivde

ABSTRACT

Objective: To develop and validate simple, rapid, linear, accurate, precise and economical UV Spectroscopic method for estimation of Valacyclovir HCl in tablet dosage form. Methods: The drug is soluble in Analytical Grade Water. The drug was identified in terms of solubility studies and on the basis of melting point done on melting point apparatus of Equiptronics. It showed absorption maxima were determined in Analytical Grade Water. The drug obeyed the Beer’s law and showed good correlation of concentration with absorption which reflect in linearity. The UV spectroscopic method was developed for estimation of Valacyclovir in tablet dosage form and also validated as per ICH guidelines. Results: The drug is freely soluble in Water, soluble in DMSO and slightly soluble in Ethanol. So, the analytical grade water is used as a diluent in method. The melting point of Valacyclovir was found to be 161-162˚C (uncorrected). It showed absorption maxima 230 nm in analytical grade Water. On the basis of absorption spectrum the working concentration was set on 15 μg/ml (PPM). The linearity was observed between 5-25 μg/ml (PPM). The results of analysis were validated by recovery studies. The recovery was found to be 98.8, 99 and 98.6% for three levels respectively. The % RSD for precision and ruggedness was found to be 077% and 0.24% respectively. Conclusion: A simple, rapid, linear, accurate, precise and economical UV Spectroscopic method has been developed for estimation of Valacyclovir in tablet dosage form. The method could be considered for the determination of Valacyclovir in quality control laboratories.

Keywords: Valacyclovir, UV Spectrophotometer, Melting Point, Assay Method, Validation, Accuracy, Linearity, Ruggedness, Precision.


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