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

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.