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Sci. Pharm. 2014, 82(2), 307-326; doi:10.3797/scipharm.1310-17

Development and Validation of a UPLC Method by the QbD-Approach for the Estimation of Rabeprazole and Levosulpiride from Capsules

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Received: 21 October 2013 / Accepted: 16 January 2014 / Published: 16 January 2014
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Abstract

Statistical experimental design was used to optimize the chromatographic separations of two pharmaceutical compounds from their respective potential impurities. A fractional factorial design was utilized to study the effects of pH, organic solvent in mobile phases A&B, and flow rate on the resolution of Rabeprazole and Rabeprazole Sulfone, which had closely eluting peaks. A desirability function applied to the optimized conditions predicted the peak resolution between 2.2 and 2.7 for the Rabeprazole & Rabeprazole Sulfone impurity. The chromatographic method employed an Acquity UPLC, BEH C18 column (100 x 2.1 mm i.d., 1.7 μm particle size) with the mobile phase consisting of a phosphate buffer, pH 6.5, and acetonitrile in a gradient program. The flow rate and injection volumes were 0.45 mL/min & 5 μl, respectively, and detection was done at 254 nm. The chromatographic method was validated for linearity, accuracy, precision, specificity, and ruggedness according to ICH guidelines. The results clearly showed that the quality by design concept could be effectively applied to optimize a UPLC chromatographic method with fewer trials and error-free experimentation.
Keywords: Rabeprazole sodium; Levosulpiride; UPLC; Method Validation; Experimental design Rabeprazole sodium; Levosulpiride; UPLC; Method Validation; Experimental design
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

THUMMALA, V.R.R.; SESHADRI, R.K.; THARLAPU, S.S.J.M.; IVATURI, M.R.; NITTALA, S.R. Development and Validation of a UPLC Method by the QbD-Approach for the Estimation of Rabeprazole and Levosulpiride from Capsules. Sci. Pharm. 2014, 82, 307-326.

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