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     2026:7/2

International Journal of Multidisciplinary Research and Growth Evaluation

ISSN: (Print) | 2582-7138 (Online) | Impact Factor: 9.54 | Open Access

A new analytical method development and validation for the estimation of bedaquiline by reverse-phase high -performance liquid chromatography

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Abstract

An efficient and simple RP-HPLC method has been developed and validated for the determination of Bedaquiline in bulk and was applied on marketed Bedaquiline products. The mobile phase used for the chromatographic runs consisted of Acetonitrile and Phosphate buffer (0.01 M, pH-3.2) in the ratio of 30:70% v/v. The separation was achieved on a Symmetry C18 ODS (4.6 mm×250 mm) 5µm particle size column using isocratic mode. Drug peak were well separated and were detected by a UV detector at 246 nm. The method was linear at the concentration range 6–14 μg/ml for Bedaquiline. The method has been validated according to ICH guidelines with respect to system suitability, specificity, precision, accuracy and robustness. Bedaquiline limit of detection (LOD) and limit of quantification (LOQ) were 0.487 μg/ml and 1.477 μg/ml respectively.

 

How to Cite This Article

Dr. Pratap Kumar Patra, Abhijith Basak, Rahiqul Islam, Bappadithya Sarkar, Chinmoy Mondal (2024). A new analytical method development and validation for the estimation of bedaquiline by reverse-phase high -performance liquid chromatography . International Journal of Multidisciplinary Research and Growth Evaluation (IJMRGE), 5(3), 424-432.

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