Rp-Hplc Method for Estimation of Anti-Viral Drug(Valaciclovir) in Pure, Solid Dosage Form and Spiked Human Plasma Using Mbth Reagent as Per Ich Guidelines

Background A novel, straightforward, accurate, repeatable, and precise chromogenic UV-visible spectroscopy and bioanalytical technique for measuring valaciclovir in pharmaceutical formulations and bulk. The MBTH reagent and Valaciclovir, in presence of ferric ammonium sulphate, undergo an oxidative condensation/coupling reaction that results in the formation of a green solution with the greatest absorption peak at 618nm. Linearity range of valaciclovir is 10–500µg/ml, and its correlation coefficient is 0.9997. Careful measurement of valaciclovir yielded a value of < 2. Validation of this method is conducted in accordance with ICH recommendationsQ2R1. Enhanced process was designed, verified, and extended to biological material using the protein precipitation extraction method. Results Valaciclovir's detection and quantification limits were 1.5114 µg/mL and 4.58 µg/mL, respectively. Human serum analysis by UV-Visible spectroscopy was created and verified. 1mL serum sample and 1mL of 0.1M was used for protein precipitation, which was vortexed and centrifuged. Standard solutionwhich had standard intensity range of 5–40 µg/mL, required 5.0 minutes to analyze. At 3.177 minutes, valaciclovir was eluted using the described technique. Valaciclovir showed linear behavior in 10–60 µg/ml range. Percentage Accuracy testing revealed that mean recovery was within region of 100%. Limits of quantitation and detection were determined to be 0.070 ng/ml and 0.212 ng/ml, respectively. Conclusion The developed approach was linear, stability indicating, sensitive, rapid, precise, and accurate. As a result, the developed method might be applied to regular quality control of tablets and bulk medications.