Abstract

METHOD DEVELOPMENT AND VALIDATION OF VALACYCLOVIR IN BULK & TABLET DOSAGE FORM BY SPECTROPHOTOMETRIC & NON AQUEOUS POTENTIOMETRIC METHOD

Sujit Kumar Sahu*, S. K. Patro and R. K. Giri

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Abstract

Two simple, sensitive, accurate, rapid visible spectrophotometric methods (A & B) and one non aqueous potentiometric titration (Method-C) have been developed for the estimation of Valacyclovir in pharmaceutical preparations. They are based on the diazotization of Valacyclovir with sodium nitrite and hydrochloric acid followed by coupling with Orcinol (Method A) to form yellow coloured chromogen, & 8-hydroxyquinolone (Method B) to form red coloured chromogen, (in alkaline medium). The absorption maxima (max) were found at 440 & 520nm for method A & B respectively. The colored chromogens formed are stable for more than 2 hours. Beer's law was obeyed in the concentration range of 50-300μg/mL for both the method A & B. Linearity range 5 to 25μg/ml was found for Method – C. The results of all the three methods have been validated statistically and by recovery studies (on the basis of ICH guidelines). The results obtained in the proposed methods are in good agreements with labeled amounts, when marketed pharmaceutical preparations are analyzed.

Keywords: Diazotization, Visible Spectrophotometric, Chromogen, Validation.