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.
An HPLC method for Tamsulosin was developed by using a quality by design (QbD) novel concept. QbD has gained importance in recent times due to regulatory requirements in industrial application. Chromatographic separation of Tamsulosin was carried out by using C8 column, and mobile phase used was methanol and distilled water (40:60 v/v) for proper separation process. Separation by using water as a solvent is beneficial as it is cost effective process and industrially applicable. In the development of the HPLC method, factors like injection volume, conc. of methanol, the column vent temperature is critical in maintaining. Hence the Box-Behnken optimization model was applied for the main, interaction and quadratic effects of these three factors on the selected response. The effect of these parameters was studied on the tailing factor (resolution). Results were analysed during a surface diagram. Verification of the software-generated result was done by taking six replicates of the run. Finally, the method was validated according to ICH guidelines.
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