Development and Validation of a Stability-Indicating Liquid Chromatographic Method for Estimating Vilazodone Hydrochloride in Pharmaceutical Dosage Form Using Quality by Design. (30th November 2016)

• Record Type: Journal Article
• Authors: Panda, Sagar Suman; Ravi Kumar, Venkata Varaha Bera; Beg, Sarwar; Sahu, Sunil Kumar; Muni, Swayamprabha
• Is Part Of: Journal of chromatographic science. Volume 54:Number 10(2016:Nov.)
• Page Start: 1713
• Page End: 1722
• Publication Date: 2016-11-30
• Subjects: Chromatographic analysis -- Periodicals; 543.8
• DOI: 10.1093/chromsci/bmw127
• Languages: English
• ISSNs: 0021-9665

Abstract

Abstract: A stability-indicating liquid chromatographic method was developed employing the principles of quality by design (QbD) to quantify vilazodone hydrochloride (VLN) in pharmaceutical dosage form. A Box–Behnken experimental design was employed to establish optimum conditions including method robustness by selecting organic phase proportion (%), mobile phase flow rate (mL/min) and pH of buffer as the factors, to study their effect on plate number as the response variable. Chromatography was performed on a C-18 column using methanol:phosphate buffer of pH 7.0 (85:15, v/v) as the mobile phase at a flow rate of 1.2 mL/min with photo diode array (PDA) detection at 285 nm. Calibration curve was linear over 5–80 µg/mL with values of accuracy within 99.4–100.8%. The limit of detection and quantification were found to be 1.5 and 5.0 µg/mL, respectively. The developed method revealed high specificity for VLN and its degradation products formed during forced degradation conditions. Furthermore, control strategies were developed based on system suitability test result. The QbD-based developed liquid chromatographic method was found suitable for routine analysis of VLN in bulk drug and pharmaceutical dosage form.