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Related Concept Videos

Drug Dissolution: Requirements and Profile Comparison01:14

Drug Dissolution: Requirements and Profile Comparison

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The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...
325

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Quality-by-Design Development of a Clofazimine-Pyrazinamide Dermal Emulsion and Its Diffusion Behavior in Strat-M<sup>®</sup> and Human Skin.

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Cracking the Skin Barrier: Models and Methods Driving Dermal Drug Delivery.

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Formulation of Topical Drug Delivery Systems Containing a Fixed-Dose Isoniazid-Rifampicin Combination Using the Self-Emulsification Mechanism.

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RP-DAD-HPLC Method for Quantitative Analysis of Clofazimine and Pyrazinamide for Inclusion in Fixed-Dose Combination

Marius Brits1, Francelle Bouwer1, Joe M Viljoen1

  • 1Faculty of Health Sciences, Centre of Excellence for Pharmaceutical Sciences (PharmacenTM), North-West University, Building G16, 11 Hoffman Street, Potchefstroom 2520, South Africa.

Methods and Protocols
|February 20, 2026
PubMed
Summary

A new reversed-phase high-performance liquid chromatography (RP-HPLC) method quantifies clofazimine and pyrazinamide in fixed-dose combination products. This validated RP-Diode Array Detection-HPLC method ensures accurate analysis for pharmaceutical quality control.

Keywords:
clofaziminehigh-performance liquid chromatography (HPLC)pyrazinamidetopical drug delivery systemtuberculosis

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Area of Science:

  • Analytical Chemistry
  • Pharmaceutical Analysis

Background:

  • Reversed-phase high-performance liquid chromatography (RP-HPLC) is crucial for pharmaceutical quality control.
  • Diode-array detection (DAD) enhances selectivity for complex mixtures like fixed-dose combination (FDC) products.

Purpose of the Study:

  • To develop and validate a quantitative RP-DAD-HPLC method for clofazimine (CFZ) and pyrazinamide (PZA).
  • To enable the analysis of CFZ and PZA within an FDC topical drug delivery system.

Main Methods:

  • RP-HPLC with a C18 column and gradient elution using aqueous formic acid and acetonitrile.
  • Detection of PZA at 254 nm and CFZ at 284 nm.
  • Validation according to ICH Q2 guidelines, including specificity, linearity, repeatability, and intermediate precision assessments. Robustness evaluated using Box-Behnken design (BBD) and response surface methodology (RSM).

Main Results:

  • The method demonstrated excellent linearity (r² = 0.9999) over the range of 7.8-500.0 µg/mL.
  • High system repeatability (%RSD ≤ 2.7%) and intermediate precision (%RSD ≤ 0.85%) were achieved.
  • The method proved robust against variations in detection wavelength, flow rate, and column temperature.

Conclusions:

  • A validated RP-DAD-HPLC method is suitable for the accurate quantitative analysis of clofazimine and pyrazinamide in FDC topical formulations.
  • This analytical approach supports the quality control of pharmaceutical products containing these active pharmaceutical ingredients.