ABSTRAKStabilitas zat aktif dalam sediaan suspensi oral sangat penting untuk diperhatikan, terutama untuk senyawa antibiotik golongan β-laktam yang mudah terhidrolisis dengan adanya air selama proses penyimpanan. Beberapa faktor yang mempengaruhi kestabilan amoksisilin dan asam klavulanat seperti pH, suhu dan lamanya penyimpanan akan mempengaruhi persentase kadar obat tersebut selama proses terapi. Pada penelitian ini, dilakukan pengembangan dan validasi metode analisis penetapan kadar amoksisilin dan asam klavulanat dalam sediaan suspensi oral menggunakan alat Kromatografi Cair Kinerja Tinggi yang dilengkapi dengan kolom C-18 Phenomenex, menggunakan campuran dapar fosfat pH 4,4-metanol dengan perbandingan 95:5 sebagai fase gerak. Laju alir yang digunakan adalah 2,0 mL/menit dan detektor UV Vis pada panjang gelombang 220 nm. Validasi metode analisis memenuhi syarat keberterimaan yaitu nilai rata-rata presisi kadar sebesar 103,42% dengan RSD 0,48% untuk amoksisilin dan 99,99% dengan RSD 1,57% untuk asam klavulanat dan hasil akurasi amoksisilin dan asam klavulanat berturutturut adalah 99,75% dan 100,83%. Baik amoksisilin maupun asam klavulanat stabil pada pH antara 6,5 - 7,0 dan mengalami penurunan kadar pada pH asam dan basa. Pengujian stabilitas sediaan suspensi kering yang telah direkonstitusi dilakukan pada suhu dinging (2-8 °C) dan suhu ruang (25-30 °C) selama 7 hari.Hasil pengujian stabilitas menunjukkan bahwa amoksisilin yang disimpan pada suhu dingin (2-8 °C) memenuhi syarat selama 7 hari dan asam klavulanat memenuhi syarat selama 5 hari. Kedua senyawa tidak stabil jika disimpan pada suhu ruang dimana penurunan kadar asam klavulanat lebih tinggi dibandingkan amoksisilin.
ABSTRACTIt is important to maintain the stability of the active substances in oral suspension, especially for β-lactam class of antibiotics that is easily hydrolyzed in the presence of water throughout the period of use. There are some factors influencing the stability of the compounds, such as pH, temperature, and storage periods thus can affect the percentage content during therapy. In this research, a High Performance Liquid Chromatography method of analysis was developed and validated. The HPLC method employed a C-18 reverse phase column Phenomenex with a mixture of sodium phosphate buffer pH 4,4 and methanol in the ratio of 95:5 as the mobile phase. The flow rate was 2 mL/min and detection was by means of a UV detector at a wavelength of 220 nm. The method validation was meet the acceptance criteria. Precision average of amoxicillin and clavulanic acid were 103,42% with RSD 0,48% and 99,99% with RSD 1,57% respectively and the accuracy for amoxicillin and clavulanic acid were 99,75% and 100,83% respectively. Both amoxicillin and clavulanic acid were stable in a range of pH 6,5 - 7,0 and the percentage of contents was decreasing in acidic and basic pH. Stability testing on reconstituted dry suspension was done at cool temperature (2-8 ° C) and at room temperatures (25-30°C) for 7 days.The results showed that amoxicillin that stored at cool temperature (2-8 °C) was stable for 7 days and clavulanic acid was stable for 5 days. Both compounds were unstable when stored at room temperatures where reduced level of clavulanic acid was higher than amoxicillin. |
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