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AQbD Approach Applied to NIR in a Complex Topical Formulation: Bifonazole as Case Study.

Lucas Chiarentin1,2,3,4, Vera Moura3, Alberto A C C Pais4

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Summary

Near-infrared spectroscopy (NIR) and RP-HPLC methods, guided by analytical quality by design (AQbD), accurately quantify bifonazole (BFZ) in creams. These validated models offer a reliable alternative for pharmaceutical quality control.

Keywords:
FT-NIRRP-HPLCanalytical quality by design (AQbD)complex formulation

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Area of Science:

  • Pharmaceutical Sciences
  • Analytical Chemistry
  • Spectroscopy

Background:

  • Developing predictive models for drug formulation behavior is crucial in pharmaceutical research.
  • Near-infrared spectroscopy (NIR) presents a non-destructive, chemically specific alternative to traditional methods.
  • Understanding molecular properties is key for reliable predictive formulation tools.

Purpose of the Study:

  • To apply a partial analytical quality by design (AQbD) approach for enhancing NIR and RP-HPLC methodologies.
  • To develop and validate chemometric models for bifonazole (BFZ) quantification in cream formulations.
  • To establish robust analytical methods for pharmaceutical quality control.

Main Methods:

  • Utilized Near-infrared spectroscopy (NIR) with multivariate data analysis for chemometric modeling.
  • Employed RP-HPLC to evaluate key performance parameters like peak area and assay.
  • Defined an analytical target profile (ATP) and conducted risk assessment using an Ishikawa diagram.

Main Results:

  • Developed accurate quantification models for bifonazole (BFZ) in cream formulations.
  • Achieved precise BFZ content determination: 8.48 mg (NIR) and 8.34 mg (RP-HPLC) with 1.25% RSD.
  • Demonstrated the reliability and robustness of both NIR and RP-HPLC methods.

Conclusions:

  • The developed NIR and RP-HPLC models are suitable for routine quality control of BFZ formulations.
  • Future work should explore real-time permeation monitoring and integration into regulatory frameworks.
  • Standardizing NIR applications in pharmaceutical quality control and formulation development is recommended.