ADIN WIRA PRAMUDITA, 051111063 (2016) VALIDASI METODE ANALISIS ERDOSTEIN SECARA KCKT YANG DIGUNAKAN PADA VALIDASI PEMBERSIHAN PERALATAN PRODUKSI DENGAN CARA USAP. Skripsi thesis, UNIVERSITAS AIRLANGGA.

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Abstract

A high performance liquid chromatography (HPLC) method for the determination of erdosteine swab samples was validated in order to control a cleaning procedure. The purpose of the present study was to obtain a valid HPLC analytical method for determining erdosteine in manufacturing equipment using swab sampling. The method was validated for specificity, limit of detection, limit of quantification, linearity, accuracy, precision, stability, and robustness. The stability result was 98.10 %-101.76 %. Limit of quantification (LOQ) and limit of detection (LOD) of method was 0.50 mg/L and 0.16 mg/L, respectively. The method was specific and showed good linearity (r = 0.9997, Vxo = 2.32%) at concentration between 0.30 and 10.03 mg/L. The recoveries were good ranging from 79.68% to 83.78%. The relative standard deviation (RSD) of repeatability and intermediate precision result was 3.26% and 4.01%, respectively. The proposed method was successfully validated and should be applied for the determination of erdosteine in manufacturing equipment using swab sampling for cleaning validation purposes.

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