YOSEPHINE MONA TESALONIKA MALELAK, 051111130 (2016) VALIDASI METODE ANALISIS KANDESARTAN SILEKSETIL SECARA KCKT UNTUK VALIDASI PEMBERSIHAN PADA PERALATAN PRODUKSI DENGAN CARA USAP. Skripsi thesis, UNIVERSITAS AIRLANGGA.

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Abstract

Cleaning validation is required to prevent cross contamination with active pharmaceutical ingredient which can affect clinically to patients. Cleaning validation samples must be analysed using validated analytical method. The aim of the present study was to obtain HPLC method used for cleaning validation of candesartan cilexetil on production equipment using swab sampling method. In this study, Phenomenex Luna C18 column (150 mm x 4.60 mm x 5 μm) is used as stationary phase and phosphate buffer pH 3.0 : acetonitrile (45 : 55) as mobile phase by setting the flow rate at 1.5 mL/min and detection at 215 nm. The method was validated for specificity, limit of detection, limit of quantification, range, linearity, accuracy, and precision. The method presented good selectivity /specificity (there is no solvent, plate and swab stick interference) and linearity (r = 0.9999 and Vxo = 0,94%) in the concentration range from 0.751 ppm to 14.414 ppm. The LOD and LOQ for candesartan cilexetil were found to be 0.22 ppm and 0.73 ppm, respectively. The recoveries were good, ranging from 89.87% to 99.31%. The precision result were good, relative standard deviation was 3.62%. The analysis of the obtained results can demonstrate that the method can be used for cleaning validation of candesartan cilexetil on production equipment using swab sampling method

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