QbD-Driven Development and Validation of a Bioanalytical LC–MS Method for Quantification of Paliperidone in Human Plasma
Abstract
This paper discusses how a Quality by Design (QbD) strategy was used to develop and test an HPLC-MS bioanalytical method for detecting plasma Paliperidone concentration. A C18 column and an isocratic mobile phase of organic solvents and water were improved for chromatographic separation. To optimise method performance, Box-Behnken design was used to study column temperature, mobile phase composition, and flow rate. The research used a logical QbD methodology to build an optimised HPLC-MS technology that meets US-FDA standards. Validation studies evaluated selectivity, sensitivity, carryover effects, matrix factor determination, linearity, accuracy and precision testing, recovery, dilution veracity, ruggedness, stability, and reinjection reproducibility, with supporting documentation. The validation studies showed the method's suitability and met acceptance requirements. The QbD framework was successfully used to build and validate an HPLC-MS bioanalytical technique for Paliperidone measurement in human plasma. This method improves chromatographic performance and Paliperidone quantification in clinical and pharmacokinetic studies.
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