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September 19, 2021
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November 11, 2021
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November 30, 2021
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Keberadaan mikroorganisme tertentu dalam produk obat dapat berpotensi mengurangi bahkan menginaktifkan aktivitas terapeutik dan berbahaya bagi kesehatan pasien. Persyaratan kualitas mikrobiologi pada produk obat tercantum dalam monografi sesuai acuan Farmakope yang berlaku. Salah satunya adalah parameter cemaran P. aeruginosa yang tidak boleh ada dalam sediaan obat. Farmakope menyatakan bahwa metode deteksi mikroba harus mampu mendeteksi mikroba dengan jumlah tidak lebih dari 100 koloni. Penelitian ini bertujuan untuk mengetahui nilai rentang Limit of Detection (LOD) dan sensitivitas metode P. aeruginosa pada produk obat. Metode deteksi P.aeruginosa mengacu pada pengujian mikroba spesifik Farmakope Indonesia VI (2020).  Deteksi P.aeruginosa di lakukan terhadap 8 produk obat yang mewakili 5 bentuk sediaan yang telah dikontaminasi dengan P. aeruginosa ATCC 9027 dengan tiga tingkat konsentrasi, yaitu ± 1 sampai 4, ±5, dan ±10 koloni per gram atau ml sampel. Berdasarkan hasil pengujian ditetapkan nilai rentang LOD dan sensitivitas metode deteksi P. aeruginosa pada produk obat, dan dianalisis secara deskriptif kualitatif.  Metode deteksi P. aeruginosa sesuai farmakope dapat mendeteksi P. aeruginosa dalam berbagai matriks sediaan obat dengan batas deteksi antara 1-10 koloni dan sensitivitas 100%. Hasil penelitian ini dapat digunakan sebagai acuan nilai LOD dalam verifikasi metode deteksi P. aeruginosa dalam produk obat. 


 


 

Kata Kunci

Indonesian Pharmacopoiea, LOD , Matrices, Pseudomonas aeruginosa, Pharmaceutical preparation, Sensitivity LOD Pseudomonas aeruginosa Pharmaceutical preparation Sensitivity

Rincian Artikel

Cara Mengutip
Aini, N., Purba, M., Triwibowo, S., Sholihatul, N., & Wulandari, R. . (2021). Penetapan Limit of Detection (LOD) dan Sensitivitas Metode Deteksi Pseudomonas aeruginosa dalam Berbagai Matriks Sediaan Obat. Eruditio : Indonesia Journal of Food and Drug Safety, 1(2). https://doi.org/10.54384/eruditio.v1i2.85
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Referensi

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