Validasi Metode Analisis Penetapan Kadar Bahan Baku Lapatinib Ditosylate secara KCKT-DAD
DOI:
https://doi.org/10.54384/eruditio.v4i1.178Kata Kunci:
Lapatinib ditosylate, KCKT-DAD, penetapan kadar, validasiAbstrak
Validasi metode penetapan kadar Lapatinib ditosylate penting dilakukan untuk meningkatkan kapabilitas dan kapasitas pengujian dalam rangka penguatan pengawasan obat yang beredar di wilayah Indonesia. Dalam melakukan pengujian tersebut diperlukan suatu metode uji yang cepat, tepat, akurat, valid, dan efisien. Penelitian penetapan kadar Lapatinib distosylate yang telah dilakukan sebelumnya umumnya menggunakan kolom C18, namun untuk efisiensi maka perlu juga dikembangkan suatu metode uji yang mampu menggunakan sumber daya yang ada di laboratorium, dimana dalam penelitian ini menggunakan jenis kolom yang berbeda, yaitu C8. Pada penelitian ini, pengembangan metode analisis penetapan kadar dilakukan pada bahan baku Lapatinib ditosylate menggunakan sistem Kromatografi Cair Kinerja Tinggi-Detektor Array Dioda (KCKT-DAD) yang dilengkapi dengan autosampler menggunakan kolom XBridge ® C8 (Waters); 250 x 4,6 mm i.d. 5 μm. Fase gerak isokratik terdiri dari pentane-1-sulfonic acid sodium salt 10 mM - asetonitril (65:35) dengan laju alir 0,6 mL/menit. Deteksi dilakukan pada panjang gelombang 222 nm. Validasi metode ditunjukkan dengan parameter uji: selektifitas, akurasi, presisi, linieritas, batas deteksi dan batas kuantifikasi. Metode penetapan kadar Lapatinib ditosylate secara KCKT- DAD menunjukkan waktu retensi 4,63 menit dengan hasil uji yang linier pada rentang konsentrasi 0,06 – 0,18 mg/mL dengan koefisien korelasi dan Vx0 berturut-turut 1,00000 dan 0,1%. Uji akurasi (% bias) diperoleh nilai sebesar 0,77% dan presisi (sistem, metode, dan intermediate) diperoleh kurang dari 2,0%. Batas deteksi dan kuantifikasi yang diperoleh secara berurutan yaitu 0,67 µg/mL dan 2,02 µg/mL. Berdasarkan hasil penelitian ini dapat disimpulkan bahwa metode yang dikembangkan memberikan performa yang cepat, akurat, dan valid.
Unduhan
Referensi
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