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Eka Putri Ramadhani
Universitas Muhammadiyah Surakarta
Agriculture, Biological Sciences & Forestry Biochemistry, Genetics & Molecular Biology Chemical Engineering, Chemistry & Bioengineering Chemistry Immunology & microbiology Materials Science & Nanotechnology Medicine & Pharmacology Nursing Public Health

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Validasi Metode High Performance Liquid Chromatography Untuk Penetapan Kadar Siproheptadin Hidroklorida Pada Tablet. Eka Putri Ramadhani; Andi Suhendi; Dedi Hanwar
Journal of Pharmaceutical and Sciences JPS Volume 9 Nomor 3 (2026)
Publisher : Fakultas Farmasi Universitas Tjut Nyak Dhien

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.36490/journal-jps.com.v9i3.1841

Abstract

Cyproheptadine hydrochloride is an antihistamine drug widely available in tablet dosage forms; therefore, a validated analytical method is required to ensure product quality. This study aimed to develop and validate a Reversed-Phase High Performance Liquid Chromatography (RP-HPLC) method for the determination of cyproheptadine hydrochloride 4 mg in tablets according to ICH Q2(R2) and USP 2024 guidelines. The analysis was performed using an XBridge C18 column (2.1 mm × 50 mm; 3.5 µm) with an isocratic mobile phase of acetonitrile:0.1% acetic acid (60:40), a flow rate of 1.0 mL/min, an injection volume of 10 µL, and PDA detection at 285 nm. Validation parameters included specificity, linearity, accuracy, precision, robustness, LOD and LOQ. The method showed excellent linearity with R² of 0.997, recovery of 100.26%, precision with % RSD of 1.42%, LOD 0.0022% and LOQ of 0.0066%. Specificity testing showed no interfering peaks, while robustness was confirmed for a ±5% change in mobile phase composition (%RSD 1.26% for retention time and 1.97% for peak area) but not for a ±5% change in flow rate, where retention time gave %RSD of 2.14%. The procedure is fit for routine quality control assay of cyproheptadine hydrochloride tablets, with the stated limitation on flow-rate robustness.
Co-Authors Andi Suhendi Dedi Hanwar