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

Author:

Somasekhar Vanita1,Gowrisankar Dannana2,Shivakumar H. N.1

Affiliation:

1. K.L.E Society’s College of Pharmacy, II Block, Rajajinagar, Bangalore – 560 010, India

2. College of Pharmaceutical Sciences, Andhra University, Visakhapatnam – 530 003, India

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 C18column (250 mmx4.6 mm) at ambient temperature. A 23factorial 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

Publisher

Hindawi Limited

Subject

General Chemistry

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