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April 22, 2026Separation Science Plus

Quality by Design Guided Stability‐Indicating HPLC Method for Concurrent Analysis of Clotrimazole and Mometasone Furoate in Cream Formulation

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Authors

DDDillip Kumar DashASAshim Kumar SenDSDhanya B. Sen

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Overview

This method shows concurrent analysis of clotrimazole and mometasone furoate in creams, indicating effective quantification strategies.

Key Points

  • The aim is to create a reliable method for quantifying clotrimazole and mometasone furoate in cream formulations.
  • Developed a stability-indicating HPLC method using a 60:40 acetonitrile-phosphate buffer mobile phase.
  • Employed factorial design for optimization and validated with ICH guidelines.
  • Conducted degradation studies to confirm separation of active components from their degradation products.
  • Achieved a linearity range of 50-600 µg/mL for clotrimazole and 5-60 µg/mL for mometasone furoate.
  • Demonstrated good sensitivity with low detection and quantification limits for both drugs.
  • Validated accuracy and precision with recoveries between 98% and 102% and % RSD < 2.

Cite This Study

Dash et al. (2026) studied this question.

synapsesocial.com/papers/69e865fd6e0dea528ddea6b1https://doi.org/10.1002/sscp.70225
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