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ISSN 2063-5346
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Development of validated stability indicating HPLC method of gallic acid and GCMS study of degradation products

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Ashish B Roge1*, Sagar N Firke2
» doi: 10.48047/ecb/2023.12.10.915

Abstract

The goal of this study was to create a validated specific stability indicating reversed-phase liquid chromatographic method for quantifying gallic acid in bulk samples in the presence of degradation products. Forced degradation studies were performed on a bulk sample of Gallic acid using acid, base, oxidative, thermal stress, and photolytic degradation to demonstrate the method's stability and power. During oxidative stress, significant degradation was observed, and the degradation product formed was identified using GCMS. There was slight degradation in acidic and alkaline stress, but no degradation in other stress conditions. Good resolution between the peaks corresponds to degradation products from the analyte were achieved on C18 column 5μ (4.6 X 250 mm) using the mobile phase consists a mixture of Orthophosphoric acid (0.1%V/V), Acetonitrile and Methanol (50:35:15 V/V/V). The detection was carried out at 270 nm. The stressed test solutions were assayed against the qualified working standard of Gallic acid indicating that the developed LC method was stability indicating. Validation of the developed LC method was carried out as per ICH requirements. The developed LC method was found to be suitable to check the quality of bulk samples of Gallic acid at the time of batch release and also during its stability studies.

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