STABILITY INDICATING LIQUID CHROMATOGRAPHIC METHOD FOR THE QUANTITATIVE DETERMINATION OF VALGANCICLOVIR IN PHARMACEUTICAL DOSAGE FORMS

  • M Mathrusri Annapurna Department of Pharmaceutical Analysis & Quality Assurance, GITAM Institute of Pharmacy, GITAM University, Visakhapatnam-530045, India
  • K Lakshmi Sai Tulasi Department of Pharmaceutical Analysis & Quality Assurance, GITAM Institute of Pharmacy, GITAM University, Visakhapatnam-530045, India
  • M Sirichandra Department of Pharmaceutical Analysis & Quality Assurance, GITAM Institute of Pharmacy, GITAM University, Visakhapatnam-530045, India

Abstract

A selective, specific and sensitive stability-indicating high-performance liquid chromatographic method was developed and validated for the determination of Valganciclovir in tablet dosage forms. Reversed-phase chromatography was performed on Shimadzu Model CBM-20A/20 Alite, equipped with SPD M20A prominence photodiode array detector (Isocratic mode) using C18 column (250 mm × 4.6 mm, 5 μm) with a flow rate of 0.8 mL/min.  UV detection was carried at 254 nm.  Linearity was observed in the concentration range of 1.0–200 μg/mL with regression equation y = 50968 x + 86374 with correlation coefficient of 0.999. The LOQ and LOD were found to be 0.8641 μg/mL and 0.2813 μg/mL respectively. Valganciclovir was subjected to stress conditions such as acidic, alkaline, oxidation, photolysis and thermal degradations. The developed method was validated as per ICH guidelines and it can be applied for the determination of Valganciclovir in pharmaceutical dosage forms.

Keywords: Valganciclovir, Isocratic mode, RP-HPLC, Validation, Stability-indicating, LOD, LOQ.

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Annapurna M, Tulasi KL, Sirichandra M. STABILITY INDICATING LIQUID CHROMATOGRAPHIC METHOD FOR THE QUANTITATIVE DETERMINATION OF VALGANCICLOVIR IN PHARMACEUTICAL DOSAGE FORMS. JDDT [Internet]. 13May2013 [cited 2Mar.2021];3(3):64-0. Available from: http://jddtonline.info/index.php/jddt/article/view/498