Efektivitas Penggunaaan Kolom Kromatografi Terhadap Validasi Metode Analisis Kadar Levetiracetam Menggunakan HPLC

Abstract

Industri farmasi telah menerapkan metode analisis obat sesuai dengan peraturan BPOM No. 23 tahun 2022 yang mengacu pada Farmakope Indonesia (FI) 2020. Metode analisis kadar levetiracetam sebelumnya menggunakan LCMS diganti menjadi metode HPLC. Pemilihan kolom C18 yang efektif akan memberikan hasil analisis yang valid. Validasi metode tersebut dilakukan dengan parameter akurasi, presisi, spesifisitas, Limit of Detection (LOD), Limit of Quantitation (LOQ), linearitas dan rentang, serta robustness. Tujuan dari penelitian ini adalah menentukan kolom C18 yang efektif untuk validasi metode analisis kadar levetiracetam. Fase diam yang digunakan berupa kolom silica C18 (4,6 µm x 15 cm, 5 µm), fase gerak dengan elusi gradien yaitu larutan A (buffer fosfat pH 5,5: asetonitril (19:1)) dan larutan B (asetonitril), serta detektor UV 205 nm. Hasil analisis menunjukkan bahwa kolom C18 kode A3 memberikan hasil yang lebih efektif dan digunakan pada validasi metode analisis kadar levetiracetam. Simpulan penelitian ini adalah kolom A3 efektif digunakan dalam validasi metode analisis kadar levetiracetam. Uji semua parameter telah memenuhi syarat keberterimaan.

The pharmaceutical industry has implemented drug analysis methods in accordance with BPOM Regulation No. 23 of 2022 which refers to Farmakope Indonesia (FI) 2020. The previous method of analyzing levetiracetam levels using LCMS was replaced by the HPLC method. An effective selection of C18 columns will give valid analysis results. Validation of such methods is done with parameters of accuracy, precision, specificity, Limit of Detection (LOD), Limit of Quantitation (LOQ), linearity and range, and robustness. The aim of this study was to determine the effective C18 column for validating the method of analyzing levetiracetam levels. The stationary phase used is a C18 silica column (4.6 mm x 15 cm, 5 µm), a mobile phase with a gradient elusion of a solution A (pH 5.5 phosphate buffer: acetonitril (19:1)) and a solution B (acetonitril), as well as a 205 nm UV detector. The results of the analysis showed that column C18 code A3 yielded more effective results and was used in validating methods of analysis of levetiracetam levels. The conclusion of this study is that the A3 column is effective in validating the method of analyzing levetiracetam levels. All parameters have qualified for compliance.