DESIGN EXPERT-SUPPORTED DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC) METHOD FOR DETERMINATION OF RESVERATROL IN BULK DRUG AND PHARMACEUTICAL FORMULATIONAbstract
The aim of the present study was to develop and validate a new, simple, selective and economical stability indicating RP-HPLC method for the quantitative determination of resveratrol in bulk drug and pharmaceutical formulations. A Box-Behnken design supported optimization was carried out to identify the optimum chromatographic conditions. The developed method was validated for linearity, range, accuracy, precision, reproducibility, LOD, LOQ and robustness as per ICH guidelines. Forced degradation studies were carried out in different stress conditions to detect degradation peak using validated method. Optimum chromatographic separation was achieved by mobile phase consisting of methanol, water and acetic acid in 69:30:1 ratio respectively. The flow rate of 1 ml min-1 with standard RT of 2.8 min was optimized in the present study. The method was linear in the concentration range of 7.5-60 µg mL-1 with a regression coefficient (R2) of 0.999. The LOD and LOQ was found to be 1.463 and 4.737 µg mL-1 respectively. Degradation study showed major decomposition of resveratrol in photolytic stress condition. The stability indicating method was found to be simple, selective and accurate for the quantitative determination of resveratrol and its impurities in drug substance and product
Rudra Pangeni, Javed Ali, Gulam Mustafa, Shrestha Sharma and Sanjula Baboota *
Department of Pharmaceutics, Faculty of Pharmacy, Hamdard University, New Delhi, India.
07 September, 2014
30 October, 2015
20 November, 2015
01 December, 2015