Validasi Metode Penetapan Kadar Metformin HCl Sediaan Kaplet Lepas Lambat menggunakan Kromatografi Cair Kinerja Tinggi

Abstract

Metformin HCl sediaan kaplet lepas lambat merupakan obat yang banyak digunakan oleh penderita diabetes tipe 2. Kualitas dari sediaan obat perlu dilakukan pengujian kadar untuk menjamin keamanannya. Kadar metformin HCl kaplet lepas lambat dapat dianalisis menggunakan KCKT yang mengacu kepada USP-NF Tahun 2023. Penelitian ini melakukan modifikasi kolom KCKT menggunakan kolom C18 4,6 x 150 mm; 5 µm (oktadesil silana (L1)) sehingga perlu dilakukan validasi metode. Parameter kesesuaian sistem, spesifisitas, linieritas, presisi, akurasi, limit deteksi, limit kuantitasi, dan robustness dengan hasil berturut-turut yakni SBR 0,153%; plasebo dan pelarut tidak menganggu analit; R2 0,998; % SBR < 2/3 CV Horwitz; recovery 97,10%; 2,552 ppm; 7,732 ppm; dan tangguh di laju alir 1,0 mL/menit telah memenuhi syarat keberterimaan sehingga dapat dikatakan valid. Selain itu, dilakukan variasi fase gerak asetonitril:dapar perbandingan (0,7:9,3); (1,0:9,0); (1,3:8,7) untuk mengetahui pengaruhnya terhadap kesesuaian sistem dan diperoleh hasil adanya pengaruh variasi tersebut pada uji kesesuaian sistem pemisahan senyawa metformin HCl.

Metformin HCl slow-release caplet preparation is a drug that is widely used by people with type 2 diabetes. The quality of the drug preparation needs to be tested to ensure its safety. The levels of slow-release caplet metformin HCl can be analyzed using HPLC which refers to USP-NF Year 2023. This study modified the HPLC column using a 4.6 x 150 mm; 5 µm C18 column (octadecyl silane (L1)) so that method validation was necessary. The parameters of system suitability, specificity, linearity, precision, accuracy, limit of detection, limit of quantitation, and robustness with consecutive results namely SBR 0.153%; placebo and solvent do not disturb the analyte; R2 0.998; % SBR < 2/3 CV Horwitz; recovery 97.10%; 2.552 ppm; 7.732 ppm; and robust at a flow rate of 1.0 mL/min have met the acceptance requirements so that it can be said to be valid. In addition, the mobile phase variation of acetonitrile: distilled water ratio (0.7:9.3); (1.0:9.0); (1.3:8.7) was carried out to determine its effect on the suitability of the system and the results obtained were the effect of these variations on the system suitability test for the separation of metformin HCl compounds.