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Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR ANALYSIS OF ACYCLOVIR IN API AND PHARMACEUTICAL DOSAGE FORM

Atul Musmade, Hemant Jain* and Rohit Prajapati

ABSTRACT

A rapid stability indicating RP-HPLC method was developed and validated for determination of Acyclovir in bulk and tablet dosage form. Sample was analysed on a Kromasil ODS C18 column (250 × 4.6 mm, 5μ). The mobile phase consist of MeCN: Ammonium acetate buffer (pH 4.5) in the ratio of 50:50 at a flow rate 1 ml min-1 with UV detection wavelength at 253 nm. The retention time of Acyclovir was 2.47 minutes. The calibration curve was linear over the concentration range of 10-60 μg/ml (r2=0.998) Acyclovir was found to degrade in alkaline and oxidative stress conditions. However it was stable in acid and dry heat conditions. The validation studies were carried out according to ICH guidlines, The developed method was found to be linear, precise, accurate and robust.

Keywords: Acyclovir, ICH, Validation, RP-HPLC.


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