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All Journal VALENSI Jurnal Ilmu Lingkungan AL KAUNIYAH JURNAL ISTEK Elkawnie Indonesian Journal of Chemistry Jurnal Riset Sains dan Kimia Terapan al Kimiya : Jurnal Ilmu Kimia dan Terapan Scientific Contributions Oil and Gas
Meyliana Wulandari
Faculty Of Mathematics And Natural Science, Universitas Negeri Jakarta
Biochemistry, Genetics & Molecular Biology Chemical Engineering, Chemistry & Bioengineering Chemistry Computer Science & IT Energy Engineering Environmental Science Materials Science & Nanotechnology

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Identification and Assay of Isoniazid and Pyrazinamide in Fixed-Dose Dispersible Tablets Containing Rifampicin Using High-Performance Liquid Chromatography Santikasari, Citra; Wulandari, Meyliana; Nafisa Ulfa, Shofi; Siregar, Mirawati; Sulaiman, Syed Azhar Syed
Jurnal Riset Sains dan Kimia Terapan Vol. 11 No. 2 (2025): Jurnal Riset Sains dan Kimia Terapan, Volume 11 Nomor 2, Desember 2025
Publisher : Program Studi Kimia Universitas Negeri Jakarta

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.21009/JRSKT.112.04

Abstract

Tuberculosis (TB) remains a major global health challenge, particularly in Indonesia, which ranks among the countries withthe highest TB burden. Fixed-dose dispersible anti-tuberculosis formulations containing rifampicin, isoniazid, and pyrazinamide are widely recommended to enhance patient adherence and minimize the risk of drug resistance. Ensuring the quality and appropriate dosage of active pharmaceutical ingredients is essential for achieving therapeutic effectiveness and maintaining TB control. This study aimed to perform routine quality assessment and regulatory compliance assays on commercialanti-TB fixed-dose combination (FDC) dispersible tablets using a reversed-phase high-performance liquid chromatography (HPLC) method as specified in the International Pharmacopoeia 2025. The HPLC system was equipped with a C18 column and used a mobile phase consisting of acetate buffer (pH 5) and methanol (94:6 v/v). System suitability testing was conducted before analysis, with %RSD values below 2%, resolution greaterthan 2.0, and tailing factors ≤ 2.0, indicating acceptable precision, selectivity, and chromatographic performance. The retention times of isoniazid and pyrazinamide were consistent with those of the reference standards, confirming identity. The assay results showed that pyrazinamide (100.3%) and isoniazid (99.9%) were within the specification limits set by the International Pharmacopoeia. These findings demonstrate that the official monograph method is suitable for regulatory-grade quality control testing of dispersible anti-tuberculosis fixed-dose combination tablets, and that the tested product met pharmacopeial quality requirements.
Co-Authors Achmad Tjachja Nugraha Agik Suprayogi Alfionita Octa Nur Zidni Andreas Andreas Anna Muawanah Aryani Satyaningtijas Farida Ariyanti Hajar Hajar Hendrawati Hendrawati Isalmi Aziz La Ode Sumarlin La Ode Sumarlin Lingga Rizal Harera Megga Ratnasari Pikoli Nafisa Ulfa, Shofi Nofrizal Nofrizal Nofrizal Nofrizal Nofrizal Syamsudin Nurhasni, N. Nurul Amilia Pandian Bothi Radja Pandian Bothi Raja Rachmi Kartini Rahminiwati, Min Santikasari, Citra Siregar, Mirawati Siti Nurbaya Syed Azhar Syed Sulaiman Syed Azhar Syed Sulaiman, Syed Azhar Syed Tety Sudiarti Verawati Verawati Zahratussaadah Zahratussaadah