MAULIDIA, 051511133169 (2019) VALIDASI METODE KROMATOGRAFI CAIR KINERJA TINGGI UNTUK PENETAPAN KADAR NISTATIN DALAM SEDIAAN OVULA. Skripsi thesis, Universitas Airlangga.

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Abstract

A high performance liquid chromatographic (HPLC) method for determination of nystatin in ovule preparation has been optimized and validated. The optimum condition of the method was achieved on Microbondapak C18 (300 x 3,9 mm, 10μm) column with the mobile phase consisting of methanol:aqua for injection in the ratio 75:25 v/v in isocratic system at the flow rate of 1,0 mL/min. The analysis was performed with PDA detector and detection was carried out at 305 nm. The column temperature was set at 25°C. Using this method, retention time of nystatin was 6.711 minutes. The validation parameters, including specificity, linearity, accuracy, and precision were evaluated. Specificity test showed that no peaks detected at retention time of nystatin. The method showed good linearity over the concentration between 6.00 and 48.00 μg/mL with correlation coefficient r > 0.9997 and Vxo < 5%. The accuracy of the method was 99.33% with precision (RSD) less than 2%. The proposed method was proved to be valid and could be used for determination of nystatin in ovule preparation.

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