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KMID : 0369820170470050413
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Jorunal of Korean Pharmaceutical Sciences
2017 Volume.47 No. 5 p.413 ~ p.427
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RP-HPLC method development using analytical QbD approach for estimation of cyanidin-3-O-glucoside in natural biopolymer based microcapsules and tablet dosage form
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Thakur Deepika
Jain Ashay
Ghoshal Gargi
Shivhare U. S.
Katare O. P.
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Abstract
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Anthocyanin has been proven to impart several health benefits and biological functions. Though, various analytical methods have been reported for single/multi-component analysis of anthocyanins, found to be tedious, time consuming and difficult to reproduce. Analytical studies on specific anthocyanins for estimation using an approach of Analytical Quality by Design are scarce. USP method is only reliable for cyanidin-3-O-glucoside (CY-3-O-Glu) estimation, but exploring many disadvantage of having high buffer concentration in mobile phase system and gradient elution, hence column blockage. So there is need to develop a novel HPLC method to overcome this problem with the use organic solvents with lesser volume of buffer in isocratic mode of elution. The aim is to develop a robust and precise method for estimation of CY-3-O-Glu in biopolymer based microcapsules and tablets. The optimized method consisted of mobile phase containing solvent A and B, flow rate 0.8 mL/min with 20 min of analysis time. The method was further validated in accordance with current ICH guidelines Q2 (R1) and found to be highly selective for component in the presence of degradation products confirmed by Mass spectra. Therefore, the proposed method was found to be suitable for routine analysis of CY-3-O-Glu in food and pharmaceutical based formulations.
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KEYWORD
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Analytical, QbD, RP-HPLC, Method development, Validation, Cyanidin-3-O-glucoside
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