VALIDATION METHODS FOR DETERMINATION OF ENROFLOXACIN LEVEL IN ANIMAL MEDICINE PRODUCTS USING HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY INSTRUMENT

https://doi.org/10.22146/ijvs.v2i1.82621

Ika Nindya Irianti(1*), Jocelyn Kurniawan(2), Agustina Dwi Wijayanti(3)

(1) Gadjah Mada University
(2) Gadjah Mada University
(3) Gadjah Mada University
(*) Corresponding Author

Abstract


Enrofloxacin is an antibiotic that is often used as a veterinary drug. Analysis of enrofloxacin in veterinary drugs can be carried out using the high-performance liquid chromatography (HPLC) method. The HPLC method was chosen because it is capable of separating the active substance to be measured from other components with high speed and efficiency. This study aims to validate the appropriate analytical method for measuring enrofloxacin levels in veterinary drug products using HPLC. The analytical method was validated using HPLC brand Shimadzu® 6.1, column C18 150 × 4.6 mm; temperature 30˚C; UV-Vis detector wavelength 278 nm; and a flow rate of 1 mL/min. The mobile phase used was a mixture of 0.05 M NaH2PO4 pH 2.5 and acetonitrile with a ratio of 65:35 (volume: volume). The sample was a standard enrofloxacin solution with a concentration of 0.1 μg/mL; 1µg/mL; and 10 μg/mL were analyzed with three replications per sample concentration. The injection volume is 20 µL per injection. The parameters measured were selectivity, linearity, accuracy, precision, limit of detection, and limit of quantification. The results showed good selectivity because the peak area of enrofloxacin was not disturbed by other components. The results of measuring the concentration of standard solutions produce a linear line equation y = 291727x + 37070 with a correlation coefficient value of 0.9999 (r = 0.9999). The accuracy value of each concentration meets the standards ranging from 99.916% to 100.762%. The results of precision calculations are relative standard deviation (RSD) ranging from 5.333% to 10.831%. The detection limit value is 0.003 µg/mL and the quantification limit value is 0.011 µg/mL. The validation test results conclude that the analytical method developed has good validity and can be used to determine enrofloxacin levels in veterinary drug products.

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References

Ambarwati, Ariyani, N. and Palupi, M. F. 2013. Validasi Metode Spektrofotometri pada Uji Kadar Sediaan Injeksi Obat Hewan Enrofloksasin. Jurnal Sain Veteriner. 31 (2): 266-273 Anastasia, Y. 2011. Teknik Analisis Residu Golongan Tetrasiklin dalam Daging Ayam Secara Kromatografi Cair Kinerja Tinggi. Buletin Teknik Pertanian. 16 (2): 68-73. Arief, R. A., Darmawan, R. D., Sunandar, Widyastuti, M. D. W., Nugroho, E., Jatikusumah, A., Putra, A. A. G., Basuno, E., Karuniawati, A., Suwandono, A., Willyanto, I., Suandy, I. and Latif, H. 2016. Penggunaan Antibiotik pada Peternakan Ayam Petelur di Provinsi Jawa Tengah, Indonesia. Dalam: Prosiding KIVNAS ke-14 PDHI, edited by Indrawati, A., Priosoeryanto, B. P., Tiuria, R., Murtini, S., Nisa, C. and Tumbelaka, L. I. T. A., Tangerang. 163- 135. Harmita. 2009. Analisis Fisikokimia. Volume 2. Penerbit Buku Kedokteran EGC. Jakarta: 1, 11, 101-103, 110, 112-115 Nurhidayati, L., Sofiah, S., Sumarny, R. and Caesar, K. 2015. Validasi Metode Kromatografi Cair Kinerja Tinggi untuk Penetapan Kadar α-Mangostin dalam Larutan Oral Ekstrak Kulit Buah Manggis (Garcinia mangostana L.). Alchemy Jurnal Penelitian Kimia. 11 (1): 38-46. Patriana, U., Werdiningsih, S., Bintang, S. and Mucharini, H. 1997. Metode Analisis Residu Obat Hewan. Balai Pengujian Mutu dan Sertifikasi Obat Hewan. 79-81 Plumb, D. 2011. Plumb's Veterinary Drug Handbook. 7th ed. PharmaVet Inc. Wisconsin. USA: 1332. Rakhmawatie, M. D. dan Rohmani, A. 2014. Optimasi dan Validasi Metode Penetapan Kadar Siprofloksasin dalam Media Mueller Hinton Broth Menggunakan HPLC (High Performance Liquid Chromatography). Jurnal Ilmu Farmasi dan Farmasi Klinik. 123-129 Ramsey, I. 2014. BSAVA Small Animal Formulary. 8th ed. British Small Animal Veterinary Association. Gloucester. UK. 139-140. Satria, R. D., Sumiarto, B., Trisyono, A. and Wijayanti, A. 2014. Pengoptimalan Metode Kromatografi Cair Kinerja Tinggi dalam Analisis Senyawa Deltamethrin Sebagai Residu dalam Produk Asal Hewan. Jurnal Kedokteran Hewan. 8 (1): 68-71. Sofyani, C., Rusdiana, T. and Chaerunnisa, A. Y. 2018. Validasi Metode Analisis Kromatografi Cair Kinerja Tinggi untuk Penetapan Kadar Uji Disolusi Terbanding Tablet Amoksisilin. Farmaka Suplemen. 16 (1): 324-330 Souza, M., Bittencourt, C. and Filho, P. 2004. Microbiological Assay for Enrofloxacin Injection. International Journal of Pharmaceutics. 271. 287-291. Sugihartini, N., Fudoli, A., Pramono, S. and Sismindari. 2014. Validasi Metode Analisa Penetapan Kadar Epigalokatekin Galat dengan Kromatografi Cair Kinerja Tinggi. Pharmaciana. 4 (2): 111-115. Sumardjo, D. 2009. Pengantar Kimia Buku Panduan Kuliah Mahasiswa Kedokteran. Penerbit Buku Kedokteran EGC. Jakarta: 423 Wijayanti, A. D. and Setiawan, D. 2017. Hubungan Kadar Albumin dan Enrofloksasin dalam Plasma Anjing yang Diterapi Enrofloksasin. Acta Veterinaria Indonesia. 5 (1): 42-46. Zahid, M. and Isnindar. 2013. Ulasan Ilmiah: Penggunaan Antibiotik Fluorokuinolon Sebagai Obat Hewan. Buletin Pengujian Mutu Obat Hewan. 12: 13-22



DOI: https://doi.org/10.22146/ijvs.v2i1.82621

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