. Analisis Pengaruh Variasi Suhu dan Kecepatan Pengadukan Disolusi Bahan Aktif Lorazepam dalam Sediaan Tablet Menggunakan KCKT

Abstract

Lorazepam merupakan obat golongan benzodiazepina yang digunakan untuk terapi gangguan kecemasan dan insomnia. Mutu sediaan tablet lorazepam dievaluasi melalui uji disolusi untuk mengetahui kemampuan zat aktif terlepas dari sediaan dan tersedia untuk diabsorpsi tubuh. Penelitian ini bertujuan menganalisis pengaruh variasi suhu dan kecepatan pengadukan terhadap hasil disolusi lorazepam menggunakan metode kromatografi cair kinerja tinggi (KCKT). Metode divalidasi melalui pengujian kesesuaian sistem, spesifisitas, linearitas, rentang, akurasi, presisi, dan robustness. Hasil validasi menunjukkan seluruh parameter memenuhi batas keberterimaan sehingga metode dinyatakan valid. Pengujian disolusi dilakukan pada suhu 25,0 °C, 37,0 °C, dan 40,0 °C serta kecepatan pengadukan 50, 75, dan 100 rpm. Kondisi optimum diperoleh pada suhu 37,0 °C dan kecepatan pengadukan 100 rpm karena menghasilkan sistem disolusi yang paling stabil dan reprodusibel.

Lorazepam is a benzodiazepine drug used for the treatment of anxiety disorders and insomnia. The quality of lorazepam tablets was evaluated through dissolution testing to determine the ability of the active ingredient to be released from the dosage form and become available for absorption. This study aimed to analyze the effects of temperature and stirring speed variations on the dissolution performance of lorazepam using High-Performance Liquid Chromatography (HPLC). The analytical method was validated through system suitability, specificity, linearity, range, accuracy, precision, and robustness tests. The validation results showed that all parameters met the acceptance criteria, indicating that the method was valid for lorazepam analysis. Dissolution testing was performed at temperatures of 25.0, 37.0, and 40.0 °C and stirring speeds of 50, 75, and 100 rpm. The optimum condition was achieved at 37.0 °C and a stirring speed of 100 rpm, which produced the most stable and reproducible dissolution system.