Development, Robustness by Design Expert and Validation of a Method for Enantiomeric Impurity Content Determination in Pretomanid Drug Substance and Pharmaceutical Dosage Form.

For the purpose of identifying enantiomeric impurities in the drug substance and pharmaceutical dosage forms of the novel anti-TB medication pretomanid, an RP-high-performance liquid chromatography method was devised. To ensure the robustness of the optimized approach, analytical quality by design was used. Studies on factor screening and risk evaluation helped pinpoint the critical method parameters (CMPs); resolution (R1), analyte retention time (R2) and tailing factor (R3) are those terms.

Development and validation of stability-indicating -HPLC method for the determination of related substances in novel nitroimidazole antituberculosis drug pretomanid: Robustness study by Design-Expert and application to stability studies.

This study developed a stability-indicating reversed-phase-HPLC method for the determination of related substances of the novel antituberculosis drug pretomanid. Critical quality attributes were evaluated and established for the robust method conditions by using quality-by-design based design of experiments. Forced degradation studies were carried out under acidic, basic, thermal, oxidative, and photolytic stress conditions.