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Research Article



Stability Indicating Method Development and Validation for Valacyclovir in Bulk and Tablet Dosage Form by Rp-Hplc

VAIJINATH G. DIGGE, S. S. PATIL, C. V. PANCHAL.




Abstract

Present study involves the development of simple, accurate, rapid, sensitive and stability indicating RP-HPLC method for the determination of Valacyclovir in bulk and tablet dosage form. In a gradient program, Acetonitrile and Phosphate buffer (pH- 6.8) were properly mixed in the ratio of 1:1. 0.9g of anhydrous disodium hydrogen phosphate and 1.298g of citric acid monohydrate were used as mobile phase. Valacyclovir has a retention time of 2.92. At a wavelength of 252nm, detection was performed. The method was validated using current ICH guidelines for method validation parameters such as specificity, linearity, system suitability, system precision, method precision and robustness. Within test ranges, the Valacyclovir showed regression (R2>0.999), and percentage recovery was found to be in between 97-99% in the marketed formulation. The method was found to be highly specific for the determination of Valacyclovir in bulk and tablet dosage form.

Key words: Valacyclovir, Method Development, Forced Degradation study, RP-HPLC, ICH Guidelines.






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