Zeitschrift für Bioanalyse und Biomedizin

Analytical Quality-By-Design Compliant Ultrafast Liquid Chromatographic Method for Determination of Paliperidone in Extended Release Tablet Dosage Form

Abstract

Sagar Suman Panda, Sarwar Beg, Ravi Kumar, Vankata Varaha Bera and Priyadarshini Singh

The current study deals with development and validation of a simple, fast and sensitive ultrafast liquid chromatographic method using the cardinal principles of analytical quality by design for estimation of paliperidone in extended release pharmaceutical dosage form. A Box-Behnken design was adopted for optimizing chromatographic conditions, especially the method robustness by selecting organic phase composition, mobile phase flow rate and strength of tetra butyl ammonium hydrogen sulfate solution as the factors, and evaluating their effect on the responses like, retention time and tailing factor. The chromatography was performed on a C-18 column (250 × 4.6 mm, 5 μm) using methanol: 10 mM tetra butyl ammonium hydrogen sulfate (95:5% v/v) as mobile phase at flow rate of 1.0 ml/min with photodiode array detection at 279 nm. Method validation studies revealed calibration curve with linearity of drug concentration ranging between 2 and 100 μg/ml. Values of accuracy were found to be well within the acceptance limit with mean percent recovery between 98.22 and 102.96%. Inter and intra-day precision showed percent RSD values were within the acceptance limits. Method sensitivity revealed that limit of detection and limit of quantitation as 0.5 μg/ml and 2 μg/ml, respectively. The system suitability analysis also yielded high degree of method robustness. Overall, the UFLC method was found suitable for determination of paliperidone in bulk and pharmaceutical dosage forms.