The document summarizes the student's industrial work experience at the Central Drug Control Laboratory of NAFDAC. It describes the various testing units of the laboratory including the High Performance Liquid Chromatography (HPLC) unit. It explains the components and working of HPLC, the system suitability test conducted on the HPLC machine, and the procedures to analyze acetaminophen tablet samples using HPLC. The student concludes that the industrial training improved their practical understanding and recommends that SIWES students should be paid to motivate learning.

1. CALEB UNIVERSITY, IMOTA LAGOS
COLLEGE OF PURE AND APPLIED SCIENCE
DEPARTMENT OF BIOLOGICAL SCIENCES AND BIOTECHNOLOGY
STUDENT’S INDUSTRIAL WORK EXPERIENCE SCHEME (SIWES) BCH 398
UNDERTAKEN AT
CENTRAL DRUG CONTROL LABORATORY (CDCL), NAFDAC
8/10, Merret Road, Medical Compoumd, Yaba, Lagos State.
PRESENTED BY
AKAN-BASSEY LAURAADEOLA
19/5816
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2. OUTLINE
• CENTRAL DRUG CONTROL LABORATORY ISO-ACCREDITED
SCOPES IN NAFDAC
• HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY LABORATORY
UNIT (HPLC)
• COMPONENTS OF HIGH-PERFORMANCE LIQUID
CHROMATOGRAPHY
• HPLC SYSTEM SUITABILITY TEST (SST)
• ANALYSIS OF ACETAMINOPHEN TABLETS SAMPLE
• CONCLUSIONS AND RECOMMENDATIONS
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3. CENTRAL DRUG CONTROL LABORATORY (CDCL) ISO-ACCREDITED
SCOPES IN NAFDAC
CDCL has testing and non-testing departmental units. The non-testing units are:
1. Central Registry Unit (CRU)
⁃ Sample Reception Unit (SRU)
⁃ Specification Archive Unit (SPAR)
⁃ Store
2. Quality Assurance Unit (QAU)
3. Instrumental Maintenance Unit (IMU)
4. Administrative Unit.
The testing units are where the analysis of samples are carried out. These are:
5. Microbiology Unit
6. Pharmacology Unit
7. Pharmaceutical Control Laboratory
8. High Performance Liquid Chromatography (HPLC)
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4. HIGH PERFORMANCE LIQUID CHROMATOGRAPHY
LABORATORY UNIT (HPLC)
The principle of High Performance Liquid Chromatography is:
• The stationary phase is a material which has small porous particles in a
column. The mobile phase is a solvent which is forced at high pressure
through the column.
• Sample is injected into the mobile phase flow to the column using an
injector.
• The component(s) (drug actives) of the sample migrate through the
column at different rates. In other words, sample flows through the
column at different velocities depending on the specific physical
interaction with the stationary phase.
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5. The common mobile phases used are miscible combination of water and other
organic solvents like acetonitrile and methanol.
• The individual substances are detected by the detector and passed on a
signal on the HPLC system.
Fig 1: HPLC Machine
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6. COMPONENETS OF HIGH-PERFORMANCE LIQUID
CHROMATOGRAPHY
Fig 2: HPLC Components
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7. HPLC SYSTEM SUITABILITY TEST (SST)
For analysis to be carried out on the HPLC system, System Suitability Test (SST) is
carried out for all conditions to be met. SST is a test carried out on the
chromatograph to verify if the system is suitable to perform in optimum condition
before carrying out an analysis. Standard solutions are used for this test. Parameters
are:
• Column efficiency
• Resolution
• Tailing factor
The chromatographic conditions that must be met before starting an analysis are:
• Flow rate
• Detector wavelength
• Specified column
• Injection volume
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8. ANALYSIS OF ACETAMINOPHEN TABLET SAMPLES
PROCEDURES:
• Solution A: 1% (v/v) glacial acetic acid in water. Sonicate for a minute.
• Solution B: Methanol (both mobile phases are poured in glass reservoirs).
• Diluent: Methanol and water (10:90). This is prepared in 1L flask
(100ml:900ml). This is used to dilute standard and sample solutions
prepared.
• Standard solution: 0.01mg/ml of Acetaminophen RS in Diluent. To obtain
a concentration of 0.01mg/ml, a standard stock is prepared by using
0.1mg/ml of Acetaminophen RS, diluted with Diluent and pipette 1ml/10ml.
Pour in vials for System Suitability Test reading.
Note: Working and Control Standard Solutions (WS and CS respectively) are
prepared and used for System Suitability Test (SST) to aid in comparison of
the peak areas of the standard and samples. 8

9. Sample Solution: Weigh 20 tablets of Paracetamol (Emzor) and
pound. Record and calculate average weight.
To obtain a concentration of 0.01mg/ml, a sample stock solution of
0.1mg/ml (5mg/50ml) is prepared:
542.92mg(AvWt) = 500mg (label claim)
xmg = 5mg
= 5.4292mg/50ml (stock solution). This is diluted with Diluent and
filled to meniscus.
- 2ml/20ml (0.1mg/ml) is pipetted and diluted to obtain 0.01mg/ml
concentration. Pass the solution through a suitable filter and pour into
vials for chromatographic reading.
- Compare the peak of interest areas of the standard and sample(s) on
the data system. 9

10. CONCLUSIONS AND RECOMMENDATIONS
• The SIWES Industrial Training with NAFDAC has improved an
avenue for me to understand the practical aspects of the theoretical
knowledge already acquired in some courses I have offered as an
undergraduate. I was exposed to different laboratory instruments and
professional work methods.
• I recommend that SIWES should endeavor to pay students to motivate
students into learning.
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11. THANK YOU FOR LISTENING
GOD BLESS YOU!
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