Evaluasi Stabilitas Kimia Bahan Baku Amlodipin Besilat terhadap Variasi Suhu dan Paparan Cahaya Menggunakan FTIR dan KCKT.

Abstract

Amlodipin besilat merupakan bahan baku obat antihipertensi golongan dihidropiridin yang menghambat masuknya ion kalsium pada otot polos pembuluh darah. Penelitian ini dilakukan untuk mengevaluasi stabilitas kimia amlodipin besilat. Sampel serbuk amlodipin besilat disimpan selama 12 minggu dengan perlakuan suhu 30 °C, 40 °C, dan 60 °C. Instrumen FTIR digunakan untuk mengidentifikasi struktur amlodipin melalui perubahan gugus fungsi. Analisis kadar dan cemaran organik menggunakan KCKT fase terbalik dengan kolom C18 dan fase gerak dapar pH 3 : metanol : asetonitril. Peningkatan suhu dan paparan cahaya mempercepat degradasi, ditandai perubahan gugus fungsi, penurunan kadar, dan peningkatan cemaran organik A pada 60 °C. Penyimpanan 30 °C dengan aluminium foil memberikan stabilitas terbaik. Perlakuan penyimpanan dan suhu tidak berpengaruh signifikan terhadap kadar, tetapi berpengaruh terhadap pembentukan cemaran organik A.

Amlodipine besylate is an antihypertensive active pharmaceutical ingredient belonging to the dihydropyridine class that inhibits calcium ion influx into vascular smooth muscle cells. This study was conducted to evaluate the chemical stability of amlodipine besylate. Amlodipine besylate powder was stored for 12 weeks under different temperature conditions of 30 °C, 40 °C, and 60 °C. Fourier Transform Infrared spectroscopy was used to identify structural changes in amlodipine through functional group alterations. The assay of the active pharmaceutical ingredient and organic impurities was performed using reversedphase High-Performance Liquid Chromatography with a C18 column and a mobile phase consisting of pH 3 buffer, methanol, and acetonitrile. The results showed that increased temperature and light exposure accelerated degradation, as indicated by functional group changes, reduced assay, and increased organic impurity A at 60 °C. Storage at 30 °C with aluminum foil provided the best stability. Statistical analysis showed that storage conditions and temperature had no significant effect on the assay of amlodipine besylate but significantly affected the formation of organic impurity A.