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System Suitability Test

Fauzan Zein M., M.Si., Apt.
High Performance Liquid Chromatography
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Contents
1. Definition
2. Factors
3. Standard Parameters
4. Calculations
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DEFINITION
System suitability testing is an integral
part of many analytical procedures. The
tests are based on the concept that the
equipment, electronics, analytical
operations and samples to be analyzed
constitute an integral system that can be
evaluated as such. System suitability test
parameters to be established for a particular
procedure depend on the type of procedure
being validated
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USP
System suitability tests are an integral part of gas
and liquid chromatographic methods. They are
used to verify that the resolution and
reproducibility of the chromatographic system
are adequate for the analysis to be done.
The tests are based upon the concept that the
equipment, electronics, analytical operations,
and samples to be analyzed constitute an
integral system that can be evaluated as such.
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Uji Kesesuaian Sistem serangkaian uji untuk
memastikan bahwa metode (analisis dg
kromatografi) dpt memberikan hasil dengan
akurasi dan presisi yg dpt diterima
Uji kesesuaian sistem biasanya dilakukan setelah
pengembangan metode dan validasi metode
selesai dilakukan
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FACTORS
1. Pemilihan Detektor tergantung dari sifat
fisikokimia analit
2. Pemilihan Fase Diam tergantung dari sifat
fisika,kimia,fisikokimia analit (lihat guidelines)
3. Pemilihan Fase Gerak jenis dan
komposisinya
4. Laju Alir
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STANDARD PARAMETERS
FDA Guidelines
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CALCULATIONS
Resolution
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CALCULATIONS
Tailing Factor
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CALCULATIONS
Tailing Factor
f = distance from the peak maximum to the leading edge of the peak, the distance being
measured at a point 5% of the peak height from the baseline.
W
0.05
= width of peak at 5% height.
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CALCULATION
the number of Theoretical Plates
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Refferences
1. Skoog, D.A., F.J.Holler, and S.R Crouch, 2007,
Principles of Instrumental Analysis, 6
th
ed.
2. Practical HPLC Method Development, 2nd
Edition
3. USP 2007
4. Ahuja, S. and Michael W.Dong (Eds.), 2005,
Handbook of Pharmaceutical Analysis by
HPLC
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Fauzan Zein M., M.Si, Apt.