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HPLC METHOD DEVELOPMENT FOR DETERMINATION OF PYRAZINAMIDE AND RELATED SUBSTANCE BY USING QUALITY BY DESIGN (QBD) APPROACH

HPLC METHOD DEVELOPMENT FOR DETERMINATION OF PYRAZINAMIDE AND RELATED SUBSTANCE BY USING QUALITY BY DESIGN (QBD) APPROACH

Author: Ashish Dalal, Mohammad Imran Anees, Faraz Khan, Mallinath Langade, Firoz A. Kalam Khan, Aniruddha Chabukswar Jaiprakash N. Sangshetti Silaev
Abstract

A robust and simplified high-performance liquid chromatography (HPLC) method was developed for the estimation of Pyrazinamide and
its related substance. A systematic approach, one of the parts of QbD (quality by design) was used in suitable analytical method
development. The HPLC segregation method was carried out with C-18 Column (3.9x300 mm, I. D. 10 µm), a mobile phase of phosphate
buffer: acetonitrile (pH 3.0) 90:10 v/v, detected at 270 nm. Optimization to this method was done by response surface methodology by
applying a three-level Box Behnken design with three center points.

Keywords: Quality by Design (QbD); HPLC; Pyrazinamide; Box-Behnken design

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