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Low level drug product API form analysis - Avalide tablet NIR quantitative method development and robustness

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This study developed a fast Near-Infrared (NIR) method to detect small amounts of Irbesartan Form B in Avalide tablets. Solid-state Nuclear Magnetic Resonance (ssNMR) verified the NIR method, ensuring accurate quality control for hypertension medication.

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Area of Science:

  • Pharmaceutical Sciences
  • Analytical Chemistry
  • Solid-State Chemistry

Background:

  • Avalide, an antihypertensive medication, combines Irbesartan and Hydrochlorothiazide.
  • Irbesartan exists in two crystalline forms: Form A (used in manufacturing) and Form B (less soluble).
  • The presence of Irbesartan Form B can negatively impact Avalide tablet dissolution and efficacy.

Purpose of the Study:

  • To develop and verify a quantitative analytical method for detecting low levels of Irbesartan Form B in Avalide tablets.
  • To assess the suitability of Near-Infrared (NIR) spectroscopy for routine quality control (QC) analysis.
  • To utilize solid-state Nuclear Magnetic Resonance (ssNMR) as an orthogonal technique for method validation.

Main Methods:

  • Method development and qualification of Near-Infrared (NIR) spectroscopy.
  • Evaluation of limit of detection, linearity, accuracy, and robustness for the NIR method.
  • Application of solid-state Nuclear Magnetic Resonance (ssNMR) for polymorphic composition determination and method verification.

Main Results:

  • Successful development and qualification of an NIR method for quantifying Irbesartan Form B.
  • Demonstrated correlation between ambient humidity and bias in Form B detection.
  • ssNMR confirmed the accuracy of the NIR method, enhancing confidence in results.
  • NIR method proved to be rapid, efficient, and suitable for QC environments.

Conclusions:

  • The developed NIR method is a reliable and efficient tool for routine analysis of Irbesartan Form B in Avalide tablets.
  • ssNMR provides orthogonal validation, increasing confidence in the NIR method's accuracy.
  • This analytical approach supports consistent product quality and therapeutic efficacy of Avalide.