What the study found
The study developed an RP-DAD-HPLC method to quantify clofazimine and pyrazinamide in a fixed-dose combination topical drug delivery system.
Why the authors say this matters
The authors state that reversed-phase high-performance liquid chromatography with diode-array detection can improve selectivity, accuracy, and reliability when testing drugs with different chemical properties in a single dosage form.
What the researchers tested
The researchers developed a chromatographic method using a C18 column, gradient elution, 0.1% aqueous formic acid and acetonitrile as mobile phases, and detection at 254 nm for pyrazinamide and 284 nm for clofazimine. They validated the method according to ICH Q2 guidelines and evaluated robustness with a three-level Box-Behnken design and response surface methodology.
What worked and what didn't
The method showed linearity from 7.8 to 500.0 µg/mL with r² = 0.9999. System repeatability was %RSD ≤ 2.7%, and intermediate precision from 25 to 500 µg/mL was %RSD ≤ 0.85%. Specificity was assessed for interference from solvents, product matrix, and degradation products, but the abstract does not report detailed failures or comparative performance problems.
What to keep in mind
The abstract does not describe limitations beyond the validation conditions reported. No clinical or product performance outcomes are given, and the summary is limited to the analytical method and its validation.
Key points
- An RP-DAD-HPLC method was developed for clofazimine and pyrazinamide.
- The method was intended for a fixed-dose combination topical drug delivery system.
- Validation followed ICH Q2 guidelines and included specificity, linearity, repeatability, and intermediate precision.
- Linearity was reported from 7.8 to 500.0 µg/mL with r² = 0.9999.
- Robustness was assessed with a Box-Behnken design and response surface methodology.
Disclosure
- Research title:
- Validated HPLC method for clofazimine and pyrazinamide analysis
- Authors:
- Marius Brits, Francelle Bouwer, Joe M. Viljoen
- Institutions:
- North-West University
- Publication date:
- 2026-01-21
- OpenAlex record:
- View
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