QbD Driven Development and Validation of UV Spectrophotometric Method for Estimation of Paliperidone in Extended Release Tablet Dosage Form

Abstract

Two novel, robust, precise and accurate UV spectrophotometric methods were developed, for the estimation of paliperidone in extended release tablets using the principle of Quality by Design. Scanning speed and sampling interval were identified as the two critical method variables, which were also evaluated by design of experiment approach, using a face-centered central composite design for establishing method robustness and method optimization. Paliperidone shows an absorption maximum at 236 nm and 273 nm using 0.1N HCl. Furthermore, area under curve method was also adopted considering 231–241 nm and 268–278 nm as the two area sections under the spectrum for validation studies. Good linearity was obtained for paliperidone over concentration of 2.5–30 μg/mL with R2> 0.99 for all the methods. The results of validation study were within acceptance limits as per ICH guidelines. The methods were robust and can be applied for routine estimation of the paliperidone in pharmaceutical dosage form.