Development and Validation of a Rapid RP-HPLC Method for the Determination of Venlafaxine Hydrochloride in Pharmaceutical Dosage forms using Experimental ... View Full Text


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Article Info

DATE

2009

AUTHORS

Vanita Somasekhar, Dannana Gowrisankar, H. N. Shivakumar

ABSTRACT

The objective of the current study was to develop a simple, accurate, precise and rapid reversed-phase HPLC method and subsequent validation as per ICH guidelines for the determination of venlafaxine hydrochloride in pharmaceutical dosage forms. The proposed RP-HPLC method utilizes a 5 μm Varian ® Microsorb-MV 100 C 18 column (250 mmx4.6 mm) at ambient temperature. A 2 3 factorial design consisting of 3 factors at 2 levels was set up to standardize the chromatographic conditions. A numerical optimization technique employing the desirability approach was used to locate the optimum chromatographic conditions. The optimum mobile phase consisted of acetonitrile, 0.04 M potassium dihydrogen phosphate buffer and methanol (45:25:30, v/v), with pH adjusted to 5.5 using 10% phosphoric acid solution. The mobile phase was delivered isocratically at a flow rate of 1 mL/min with UV detection at 224 nm. The calibration plots constructed using the optimized chromatographic conditions displayed good linear relationship in the concentration range of 1-50 μg/mL with r=0.9992. The method was validated for precision, accuracy, robustness and recovery. The minimum detectable and minimum quantifiable amounts were found to be 0.568 and 1.72 μg/mL, respectively and the method was found to be reproducible from the statistical data generated. Venlafaxine hydrochloride was eluted at 3.43 min More... »

PAGES

1091-1102

Identifiers

URI

http://scigraph.springernature.com/pub.10.1155/2009/870692

DOI

http://dx.doi.org/10.1155/2009/870692

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1028431499


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