Mon, 18 Dec 2017

A Novel Validated RP HPLC Method for the Estimation of Vilazodone in Bulk and Pharmaceutical Dosage Form

P. Ravisankar1*, S. Gowthami1, CH. Devadasu1, P. Srinivasa Babu1, P.Venkateswar Reddy2

1. Department of Pharmaceutical Analysis and Quality Assurance, Vignan Pharmacy College, Vadlamudi, Guntur- 522 213. Andhra Pradesh, India.

2. Hetero drugs Limited, Jeedimetla, Hyderabad-500 055,Andhra Pradesh, India.


ABSTRACT

A novel, convenient, accurate, precise and reproducible reverse phase high performance liquid chromatography was developed and validated for the estimation of Vilazodone in bulk and pharmaceutical tablet dosage form. Objective was achieved under optimized chromatographic conditions on Shimadzu LC-20AT Prominence Liquid Chromatograph with Welchrom C18 isocratic column, (250 mm × 4.6 mm i.d., particle size 5 μm, maintained at ambient temperature), is used as stationary phase. An isocratic mode with mobile phase consisting of Acetonitrile: Water (50:50 v/v), with apparent pH of 3.3, at a flow rate of 1.0 mL/minutes. The effluent was monitored at 240 nm using Shimadzu SPD-20A prominence UV-Vis detector. The retention time of Vilazodone was found to be 4.103 minutes. The linearity range was found to be 1-5 μg/mL with correlation coefficient (R2) is 0.999. Validation parameters such as specificity, linearity, precision, accuracy, and robustness, limit of detection (LOD) and limit of quantitation (LOQ) were evaluated for the method according to the International Conference on Harmonization ICH Q2 (R1) guidelines. The LOD and the LOQ were found to be 0.044 μg/mL and 0.135 μg/mL respectively. Recovery of Vilazodone was found to be in the range of 99.80 % - 99.92 %. The method was validated statistically using the % RSD and the values are found to be within the limits. Therefore this method was conveniently and easily applied for the quantitative determination of Vilazodone in pharmaceutical dosage forms.

Keywords: Vilazodone, LOD, LOQ, Recovery studies, ICH guidelines.


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