VALIDASI METODE ANALISIS

IDEENTIFIKASI KUALITATIF DAN VALIDASI METODE ANALISISAbdul Rohman, Ph.D., M.Si., AptTATA CARA PERKULIAHANKuliah adalah 2 sksKuliah 2 X @ 50 menit (setiap pertemuan)Selama perkuliahan HP di matikan/di vibrasiTatap muka di depan kelas (penjelasan, tanya jawab)Pemberian tugasUjian :a. tengah semesterb. akhir semesterc. closed book, assay

EVALUASIMahasiswa :- hasil ujian (UTS, UAS)

Dosen :- angket dari mahasiswa (kritik dan saran tentang perkuliahan dan ujian )

Komponen PenilaianTugas: 20 %UTS: 40 %UAS: 40 %SILABUS MATA KULIAH

MATERI KULIAHPendahuluan Analisis kimia: kualitatifIdentifikasi kualitatifKimia basahSpektrofotometri InframerahKromatografiValidasi dan pengenalan ISO 17025Pengenalan sumber kesalahan dalam setiap tahapan analisisKualifikasi instrument analitikSpektro UV-visAASKromatografParameter validasiLinieritasPresisiAkurasiSensitifitasRobutsnessRuggedness

MATERI KULIAHBerbagai jenis Penjaminan mutu analisis kimiaPenjaminan mutu internalControl chartUji profisiensiDiskusi/presentasi tentang validasi metode analisis

ReferensiAuterhoff, H. and Kovar, K.A., 1987, Identifikasi Obat, diterjemahkan oleh: Sugiarso, N.C. (1987), Penerbit ITB Bandung. Ahuja, S. and Rasmussen, H., 2007, HPLC method development for pharmaceuticals, vol.8, Separation science and technology, Elsevier, Academic Press, Amsterdam.Chan, C.C., Lam, H., Lee, Y.C., and Zhang, X.M., 2004, Analytical method validation and instrument performance verification, Wiley-Interscience, John Wiley & Sons Inc., Hoboken, New Jersey.Ermer, J. and Miller, J.H.M., 2005, Method validation in pharmaceutical analysis, A guide to best pactice, Wiley-VCH Verlag GmbH, Weinheim.Miller, J. and Miller, J.C. 2005. Statistics and Chemometrics for Analytical Chemistry. 5th Edition, Pearso Education Limited, Edinburgh Gate Harlow, England.Eurachem, 1998, The fitness for purpose of analytical method: A laboratory guide to method validation and related topics, diakses dari: http:// www.eurachem.org/guides/pdf/valid.pdf.

References (Lanjutan)E. Prichard and V. Barwick (2007). Quality assurance in Analytical ChemistryB. Hibbert (2007). Quality assurance for the analytical chemistry laboratories.H.Y. Aboul-Enein et al. (2000). Quality and reliability in analytical chemistry.IUPAC (2006). The international harmonized protocol for the proficiency testing of analytical chemistry laboratories.Uerachem (2000). Quantifying uncertainty in analytical measurementsISO/IEC 17025: 2005. General requirements for the competence of testing and calibration laboratories.Gonzalez, A.G., Herrador, M.A., 2007 A Practical Guide to Analytical Method Validation, Including Measurement Uncertainty and Accuracy Profiles, Trends in Analytical Chemistry 26: 3.

Tugas PresentaasiMembuat makalah tentang Validasi metode analisis dan mempresentasikan dalam bentuk ppt di 3 pertemuan terakhirTopik makalahnya adalah:Validasi metode analisis sampel biomedisValidasi metode analisis dalam sediaan farmasiValidasi metode analisis dalam impurities