A Comprehensive Study of RP-HPLC Method Development for Bedaquiline: Leveraging Quality by Design for Optimal Separation, Identification, and Quantification in Anti-Tuberculosis Drug Analysis

Abstract

This study presents a simple method to set up and test RP-HPLC for Bedaquiline This drug is used to treat tuberculosis. We used a weQuality by Design (QbD) approach. A strong and fast RP-HPLC method was created to measure Bedaquiline in drugs. It is accurate and specific for both qualitative and quantitative analysis. The method uses a mobile phase with Methanol and 0.1%orthotic Phosphoric Acid. It also employs a C18 column and detects at a wavelength of 242 nm. Using QbD principles for method development helped identify critical method parameters (CMPs). This led to a clearer understanding of variability and made the methods more robust. Validation was carried out per ICH Q2(R1) guidelines. The method showed great linearity (r2 = 0.9999), precision, accuracy, and specificity. The limits of detection (LOD) and quantification (LOQ) were 3 µg/mL and 12 µg/mL, respectively. This optimized method can be reliably used for routine analysis of Bedaquiline.