Literature Review: Validasi Metode Analisis Penetapan Kadar Metformin Dalam Plasma Dengan Berbagai Metode
Keywords:
Penetapan kadar , Metformin, Plasma, Validasi metodeAbstract
Pendahuluan: Metformin merupakan obat lini pertama untuk pengobatan Diabetes Mellitus tipe 2, yang memerlukan pemantauan kadar plasma guna mengoptimalkan terapi. Penentuan kadar metformin dalam plasma memerlukan metode analitis yang valid dan andal. Tujuan: Mengidentifikasi dan membandingkan parameter validasi metode analitik dalam menentukan kadar metformin dalam plasma, termasuk selektivitas, linearitas, batas deteksi (LOD), batas kuantifikasi (LOQ), akurasi, dan presisi (intraday dan interday), melalui studi literatur. Metode: Studi literatur deskriptif dengan menelusuri artikel-artikel dalam basis data Google Scholar, PubMed, dan Semantic Scholar periode 2015–2025. Kriteria inklusi mencakup jurnal-jurnal yang membahas validasi metode untuk menentukan kadar metformin dalam plasma, dapat diakses teks lengkap, bahasa Indonesia atau Inggris, serta diterbitkan dalam jurnal-jurnal terakreditasi/bereputasi. Hasil: Empat belas artikel memenuhi kriteria inklusi. Metode yang digunakan meliputi RP-HPLC, HPLC-UV, LC-MS/MS, HILIC/ESI-MS, UHPLC-MS/MS, dan UPLC-MS/MS. Parameter validasi menunjukkan selektivitas yang baik pada ke-14 metode tersebut, linearitas dengan R² = 0,9913–0,9999 disertai persamaan regresi linier yang mencerminkan karakteristik masing-masing sistem deteksi, Batas Deteksi sebesar 0,02–2,18 μg/mL dan Batas Kuantitasi sebesar 0,05–10,03 μg/mL, akurasi sebesar 81–105,5% (11 dari 14 metode memenuhi kriteria FDA), serta presisi intraday RSD sebesar 0,12–19,7% dan presisi interday RSD sebesar 0,04–16,35%. Kesimpulan: Metode RP-HPLC dengan pendekatan Analytical Quality by Design (AQbD) merupakan metode yang paling optimal dan seimbang untuk menentukan kadar metformin dalam plasma dalam hal linearitas (R² = 0,9999), sensitivitas (Batas Deteksi 0,18 μg/mL; Batas Kuantitasi 0,50 μg/mL), akurasi (97,2–101,21%), dan presisi (RSD < 2%), serta hemat biaya untuk pemantauan terapi rutin. Metode berbasis MS/MS direkomendasikan untuk aplikasi yang memerlukan sensitivitas sangat tinggi, seperti studi farmakokinetik.
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