DEVELOPMENT OF VALIDATED UV SPECTROPHOTOMETRIC STABILITY INDICATING METHOD FOR ESTIMATION OF GALLIC ACID IN BULK FORM

Author(s): A B Roge* and G R Shendarkar

Abstract: A novel simple, reliable, rapid and accurate UV spectrophotometric stability indicating method (SIM) was developed for estimation of gallic acid from bulk powder. The study was carried out at 220 nm. Gallic acid has shown linear absorbance over the concentration range of 4-20 μg/Ml with R2 value 0.999. This 𝑦=0.061 𝑥+0.016 was used for determination of concentrations of test solution. The proposed method was validated as per ICH Q2 (R1) guidelines for various parameters eg. Prcision, accuracy, limit of detection (LOD), limit of quantification (LOQ) and linearity and range. Results of validation study has shown compliance with criteria of ICH guidelines. Relative standard deviation was found less than 2% and recovery was found in range 98.6- 100.63 %. Method was very sensitive as LOD and LOQ were found to be 0.147 μg/mL and 0.447 μg/mL respectvely. Stability indicating potential was studied by anlysing sample subjected to various stress conditions like hydrolysis, oxidation, photodegradation and thermal degradtions. Proposed method reveals that gallic acid was found to be unstable at hydrolytic and oxidative stress conditions.

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