Validasi Metode High Performance Liquid Chromatography Untuk Penetapan Kadar Siproheptadin Hidroklorida Pada Tablet.
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Siproheptadin hidroklorida merupakan obat antihistamin yang tersedia luas dalam bentuk tablet, sehingga diperlukan metode analisis tervalidasi untuk menjamin mutu produk. Penelitian ini bertujuan mengembangkan dan memvalidasi metode Reversed-Phase High Performance Liquid Chromatography (RP-HPLC) untuk penetapan kadar siproheptadin hidroklorida 4 mg dalam tablet berdasarkan pedoman ICH Q2(R2) dan USP 2024. Analisis dilakukan menggunakan kolom XBridge C18 (2,1 mm × 50 mm; 3,5 µm) dengan fase gerak asetonitril:asam asetat 0,1% (60:40) secara isokratik, laju alir 1,0 mL/menit, volume injeksi 10 µL, dan deteksi PDA 285 nm. Validasi meliputi spesifisitas, linearitas, akurasi, presisi, robustness, LOD dan LOQ. Metode menunjukkan linearitas yang baik dengan nilai R² 0,997, recovery 100,26%, presisi (% RSD) 1,42%, LOD 0,0022% dan LOQ 0,0066%. Uji spesifisitas menunjukkan tidak adanya puncak pengganggu, dan robustness terpenuhi terhadap perubahan komposisi fase gerak ±5% (% RSD 1,26% untuk waktu retensi dan 1,97% untuk luas area), tetapi tidak terpenuhi terhadap perubahan laju alir ±5% dengan % RSD waktu retensi 2,14%. Prosedur ini layak digunakan untuk analisis rutin pengawasan mutu tablet siproheptadin hidroklorida dengan keterbatasan pada robustness laju alir.
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Referensi
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