A Validated Stability Indicating HPTLC Method for Estimation of Acyclovir in Tablets in presence of its alkaline hydrolysis degradation product

Publication date: Available online 1 October 2014 Source:Bulletin of Faculty of Pharmacy, Cairo University Author(s): Pallavi M. Patil , Sagar B. W.hede , Praveen D. Chaudhari A sensitive stability indicating high-performance thin-layer chromatographic method was developed and validated for quantitative determination of Acyclovir in tablets. Chromatographic separation was performed on a precoated silica gel 60F254 HPTLC plates using Toluene: n-Butanol: Methanol: Water (5.0:3.0:1.0:1.0 v/v/v/v) as a mobile phase. A TLC scanner set at 259nm was used for direct evaluation of the chromatograms in reflectance/absorbance mode. Acyclovir and degradant were satisfactorily resolved with Rf values of 0.62±0.05, 0.78±0.05, respectively. Calibration curve was a polynomial in the concentration range of 200–1000ng/band. The high correlation coefficient (r2>0.9991) values indicated clear correlations between the investigated compound concentrations and their peak areas within the test ranges. The method was validated according to ICH guidelines. The repeatability and intermediate precision, expressed by the RSD, were less than 2.0%. The accuracy and validity of the method were further ascertained by performing recovery studies via a standard addition method. The accuracy of the method expressed as percent recovery was satisfactory (99.85%). The drug was subjected to the International Conference on Harmonization (ICH)-prescribed hydrolytic, oxidative, photolytic and thermal...
Source: Bulletin of Faculty of Pharmacy, Cairo University - Category: Drugs & Pharmacology Source Type: research