Application of Analytical Quality by Design concept for bilastine and its degradation impurities determination by hydrophilic interaction liquid chromatographic method

Design of Experiments (DoE) applied to Pharmaceutical and Analytical Quality by Design (QbD)

“…Tetrabutyl ammonium hydroxide concentration, buffer pH and organic phase concentration Capacity factor of eberconazole nitrate (reverse phase HPLC method) (Krishna et al, 2016) Central composite design Cyclodextrin concentration, pH, and voltage Resolution between peaks and analysis time of a clycodextrin-modified micellar electrokinetic chromatography (Orlandini et al, 2016) Box-Behnken design Acetonitrile content in mobile phase, ammonium acetate concentration in the aqueous phase, and pH of aqueous phase Retention factor of impurity and selectivity of critical peal pair in bilastine and its degradation impurities determination by liquid chromatographic method (Terzic et al, 2016) Placket-Burman design Temperature, pH, buffer concentration, and L-asparaginase concentration Absorvance at 450 nm, usedfor L-asparaginase activity method (Yao et al, 2016) Fractionate factorial design Time of dissolution, volume of dissolution media, pH of dissolution media, and rotation speed Amount of acetaminophen dissolved during (Romero, Lourenço, 2017) as recent examples of the utilization of DoE in the development and optimization of analytical methods. DoE tools help to identify and explain how critical analytical parameters (CAPs) (independent variables) affects the analytical method performance characteristics (AMPC) (dependent variables) and, therefore, the analytical target profile (ATP).…”

Prediction of Analyte Retention Time in Liquid Chromatography

“…A number of studies − have been published on the application of DoE principles in the HILIC mode for exploring the retention mechanism as well as searching for the optimal separation conditions for target analyses. Central composite and fractional factorial designs were used for optimization of the HILIC separation of amlodipine besylate and bisoprolol fumarate in pharmaceuticals using a diol column .…”

Key information related to quality by design (QbD) applications in analytical methods development

“…Terzić et al [47] developed a specific and robust hydrophilic interaction liquid chromatography (HILIC) method for the determination of bilastine and its degradation impurities with high analytical frequency following analytical QbD (AQbD) strategy. Through the use of BBD, a relationship between the CPPs and the CQAs was established, and further regression models and Monte Carlo simulations were used to identify the DS.…”