Abstract
BackgroundA simple, rapid and accurate reverse phase RP-HPLC method for the validation of antitubercular drug bedaquiline fumarate (BQF) was developed. The stability and forced degradation behaviour of bedaquiline fumarate (BQF) in official dissolution media (0.01 N HCl) and methanol were assessed.ResultsThe method provided linear responses within the concentration range which varies from 10 to 100 μg/mL with LOD values of 2.6 μg/mL and LOQ of 7.9 μg/mL. Mean percent recovery varied between 97.46 and 103.82% and precise mean RSD of 0.31% (repeatability) and 0.48% (intermediate precision). The method was validated for other parameters like specificity, system suitability and robustness. Potential degradation of the BQF when exposed to direct sunlight in official dissolution media was 90.75% and in methanolic stock solution was 91.98%. Acid-alkali degradation study showed 86.59% loss of BQF in 0.5 N NaOH, and in acidic environment (0.5 N HCl), there was 6.15% loss. Thermal degradation of BQF was 70.11% loss in official dissolution media at 80 °C. No significant change in drug concentrations was noted when exposed and protected from normal daylight at room temperature and at 2–8 °C temperature.ConclusionThe developed method has significant applicability for the qualitative and quantitative determination of BQF in different pharmaceutical formulations in the official dissolution media in routine quality control analysis.
Highlights
A simple, rapid and accurate reverse phase RP-High-performance liquid chromatography (HPLC) method for the validation of antitubercular drug bedaquiline fumarate (BQF) was developed
Bedaquiline fumarate (BQF) is a diarylquinoline derivative (Fig. 1) approved by the USFDA in 2012 with the accelerated approval pathway [5]. This drug was developed by Janssen Pharmaceutical (Johnson & Johnson) by Dr Koen Andries and his team and marketed under the brand name ‘SIRTURO®’ for the treatment of multidrug resistance (MDR) pulmonary tuberculosis in combination with first line TB therapy [5, 6]
Instrumentation The liquid chromatographic system used in the present work was consisted of Waters 1525 binary pump system with inline degasser, Waters 2707 auto sampler, column oven, Waters 2998 Photodiode Array (PDA) detector and the EMPOWER 2.0 software for data acquisition and processing
Summary
A simple, rapid and accurate reverse phase RP-HPLC method for the validation of antitubercular drug bedaquiline fumarate (BQF) was developed. Greater than 95% deaths occurred in the developing countries whereas 50%. Bedaquiline fumarate (BQF) is a diarylquinoline derivative (Fig. 1) approved by the USFDA in 2012 with the accelerated approval pathway [5]. This drug was developed by Janssen Pharmaceutical (Johnson & Johnson) by Dr Koen Andries and his team and marketed under the brand name ‘SIRTURO®’ for the treatment of multidrug resistance (MDR) pulmonary tuberculosis in combination with first line TB therapy [5, 6]. Bedaquiline fumarate kills the superbug by inhibiting the enzyme ATP synthase which plays a vital
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
