Jurnal Biologi Tropis
Vol. 25 No. 3 (2025): Juli-September

Optimization and Validation of Clobazam Content Determination Method in Tablet Preparations Using High Performance Liquid Chromatography (HPLC)

Agustina, Rosita (Unknown)
Mulyadi, Dikdik (Unknown)
Yuningsih, Lela Mukmilah (Unknown)



Article Info

Publish Date
30 Jul 2025

Abstract

Clobazam is a tablet-shaped drug whose concentration was analyzed using the HPLC separation method. Analysis of clobazam concentration using a method in accordance with FI VI, with a mobile phase composition of 70 mL of water and 30 mL of acetonitrile, resulting in a retention time of 21 minutes. The purpose of this study was to obtain the most optimal composition of the mobile phase and column to obtain a faster retention time in the analysis of clobazam levels. As well as to validate the analysis method whose results are in accordance with the validation requirements in the Indonesian pharmacopoeia VI. Data were analyzed using linearity tests, specificity or selectivity tests, accuracy tests, repeatability and intermediate precision tests, robustness tests, and LOS and LOQ tests. The results showed a theoretical plate number of 1711.5, a tailing factor of 1.34, and a retention time of 1.69 minutes using a C18 column measuring 150 x 3 mm 3 μm with a mobile phase ratio of acetonitrile: water of 80:20. The validation results of the analytical method for accuracy, precision, selectivity, and robustness showed RSD <2%, Detection Limit (LOD) 0.0014 mg/mL, Quantification Limit (LOQ) 0.0042 mg/mL, and the linearity test results showed a correlation coefficient of 0.999, meeting the FI VI validation criteria. The conclusion is that differences in the composition of the mobile phase and the particle size of the column greatly affect the characteristics of the chromatogram produced in HPLC analysis.

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Journal Info

Abbrev

JBT

Publisher

Subject

Agriculture, Biological Sciences & Forestry Biochemistry, Genetics & Molecular Biology Immunology & microbiology

Description

Jurnal Biologi Tropis (ISSN Cetak 1411-9587 dan ISSN Online 2549-7863) diterbitkan mulai tahun 2000 dengan frekuensi 2 kali setahun oleh Program Studi Pendidikan Biologi PMIPA FKIP Universitas Mataram, berisi hasil penelitian dan ulasan Ilmiah dalam bidang Biologi ...