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

QbD Driven Development and Validation of UV Spectrophotometric Method for Estimation of... AbstractTwo 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. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Analytical Chemistry Letters Taylor & Francis

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

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

Abstract

AbstractTwo 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...
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Publisher
Taylor & Francis
Copyright
© 2018 Har Krishan Bhalla & Sons
ISSN
2230-7532
eISSN
2229-7928
DOI
10.1080/22297928.2018.1446845
Publisher site
See Article on Publisher Site

Abstract

AbstractTwo 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.

Journal

Analytical Chemistry Letters – Taylor & Francis

Published: Jul 4, 2018

Keywords: Paliperidone; UV spectrophotometry; Quality by Design; Central Composite Design; robustness

References

  • Spectrophotometric determination of paliperidone palmitate in tablets
  • Spectrophotometric methods for the quantitative estimation of paliperidone in formulations
  • New method development and validation of UV spectrophoto-meter for the estimation of paliperidone in bulk and pharmaceutical dosage form
  • A validated spectro-photometric method for determination of paliperidone palmitate in bulk drug and its pharmaceutical dosage form
  • Joseph M. Juran, a perspective on past contributions and future impact
  • Spectrophotometric Determination of Sertaconazole Nitrate in Pharmaceutical Dosage Form using Quality by Design (QbD) Framework