What the study found
The study found that a reversed-phase high-performance liquid chromatography method with diode-array detection (RP-DAD-HPLC) was developed and validated for measuring clofazimine and pyrazinamide in a fixed-dose combination topical drug delivery system. The method was designed to separate and quantify both drugs in one analytical procedure.
Why the authors say this matters
The authors state that reversed-phase high-performance liquid chromatography is widely used in pharmaceutical development and quality control, and that adding diode-array detection improves selectivity when testing drugs with different chemical properties in the same dosage form. The study suggests this is relevant for finished pharmaceutical products and fixed-dose combination products.
What the researchers tested
The researchers developed an RP-DAD-HPLC 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 assessed specificity, linearity, repeatability, intermediate precision, and robustness.
What worked and what didn't
The method showed linearity from 7.8 to 500.0 µg/mL with an r2 value of 0.9999. Reported precision was good, with system repeatability of %RSD ≤ 2.7% and intermediate precision of %RSD ≤ 0.85%. Robustness was evaluated with a three-level Box–Behnken design and response surface methodology, but the abstract does not report any specific robustness outcomes or failures.
What to keep in mind
The available summary does not provide detailed numerical results for specificity or robustness beyond the validation approach. It also does not describe performance in real product samples beyond stating that the method was intended for inclusion in a fixed-dose combination topical drug delivery system.
Key points
- An RP-DAD-HPLC method was developed for clofazimine and pyrazinamide.
- The method was validated under ICH Q2 guidelines.
- Linearity was reported from 7.8 to 500.0 µg/mL with r2 = 0.9999.
- System repeatability was %RSD ≤ 2.7%, and intermediate precision was %RSD ≤ 0.85%.
- Robustness was tested using a Box–Behnken design and response surface methodology.
Disclosure
- Research title:
- Validated HPLC method quantified clofazimine and pyrazinamide
- Authors:
- Marius Brits, Francelle Bouwer, Joe M. Viljoen
- Institutions:
- North-West University, North-West University, North-West University
- Publication date:
- 2026-01-21
- DOI:
- 10.3390/mps9010016
- OpenAlex record:
- View
Get the weekly research newsletter
Stay current with scholarly research without reading academic papers — one filtered digest, every Friday.