Development and Validation of RP-HPLC for Determination Bedaquiline Fumarate in Nanostructured Lipid Carriers, Tablets, and Human Plasma Using Design of Experiment Method; [Tasarım Deney Yöntemi Kullanılarak Nanoyapılı Lipid Taşıyıcılar, Tabletler ve İnsan Plazmasında Bedaquilin Fumarat Tayini İçin RP-HPLC Yönteminin Geliştirilmesi ve Validasyonu]

Asti Rahayu; S. Satrialdi; Neng Fisheri Kurniati; Rachmat Mauludin

doi:10.55262/fabadeczacilik.1753199

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Development and Validation of RP-HPLC for Determination Bedaquiline Fumarate in Nanostructured Lipid Carriers, Tablets, and Human Plasma Using Design of Experiment Method; [Tasarım Deney Yöntemi Kullanılarak Nanoyapılı Lipid Taşıyıcılar, Tabletler ve İnsan Plazmasında Bedaquilin Fumarat Tayini İçin RP-HPLC Yönteminin Geliştirilmesi ve Validasyonu]

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Asti Rahayu, S. Satrialdi, Neng Fisheri Kurniati, Rachmat Mauludin

2026 Fabad Journal of Pharmaceutical Sciences Vol. 51 Issue 1 Article Cited by 0

Abstract

A reversed-phase HPLC (RP-HPLC) technique was established to quantify Bedaquiline fumarate (BDQ), a hydrophobic drug for multidrug-resistant tuberculosis. Effective separation was achieved with a mobile phase of methanol and ammonium acetate buffer (pH 4.7) in a 85:15 (v/v) ratio, at a flow rate of 1.2 mL/min. The validated method exhibited excellent linearity in multiple matrices: tablet formulations (20-200 µg/mL; R²=0.9993), nanostructured lipid carriers (NLCs) (40-300 µg/mL; R²=0.9991), and human plasma (0.1-10 µg/mL; R²=0.9975). Method sensitivity was confirmed with limits of detection (0.7483 µg/mL) and limit of quantification (2.2677 µg/mL). Comprehensive validation demonstrated satisfactory recovery rates (98-102%), precision, and robustness (relative standard deviation <2%), meeting all International Council for Harmonisation requirements. This study presents a systematically optimized RP-HPLC method for the quantification of BDQ. The main advantages over existing methods include a significantly shorter retention time (<3 minutes) achieved through DoE optimization and successful validation across diverse sample types (tablets, NLCs, and human plasma), and offering a reliable time-efficient solution for routine analysis. © 2026, Society of Pharmaceutical Sciences of Ankara (FABAD). All rights reserved.

Affiliations

School of Pharmacy, Institut Teknologi Bandung, Bandung, Indonesia; Department of Pharmaceutics, Faculty of Health Sciences, Universitas PGRI Adi Buana Surabaya, Surabaya, Indonesia; Department of Pharmaceutics, School of Pharmacy, Institut Teknologi Bandung, Bandung, Indonesia; Department of Pharmacology and Clinical Pharmacy, School of Pharmacy, Institut Teknologi Bandung, Bandung, Indonesia

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