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Table of Contents
Chapter
Page
1 Introduction.................................................................................................................................................. 5
2 Health & Safety............................................................................................................................................. 9
3 Visual Inspection.......................................................................................................................................... 10
4 Disintegration Testing.................................................................................................................................. 13
5 Thin Layer Chromatographic Testing........................................................................................................... 14
5.1 How does a TLC system work.......................................................................................................... 14
5.2 Stationary phase............................................................................................................................... 15
5.3 Mobile phase.................................................................................................................................... 16
5.4 Sample preparation.......................................................................................................................... 17
5.5 Sample application........................................................................................................................... 21
5.6 Chromatoplate development............................................................................................................ 23
5.7 Sample detection............................................................................................................................. 24
5.8 Chromatoplate reading.................................................................................................................... 27
5.9 Relative retention factor.................................................................................................................... 28
5.10 TLC handling and sample errors....................................................................................................... 29
5.11 Cleaning and disposal....................................................................................................................... 30
6 Individual Test Procedures........................................................................................................................... 31
6.1 Acetylsalicylic Acid (Aspirin).............................................................................................................. 32
6.2 Aminophylline.................................................................................................................................. 36
6.3 Amodiaquine (as free base and hydrochloride)................................................................................. 40
6.4 Amoxicillin....................................................................................................................................... 44
6.5 Ampicillin......................................................................................................................................... 48
6.6 Artemether*..................................................................................................................................... 52
6.7 Artesunate........................................................................................................................................ 56
6.8 Cephalexin....................................................................................................................................... 60
6.9 Chloramphenicol.............................................................................................................................. 64
6.10 Chloroquine (as phosphate and sulphate)........................................................................................ 68
6.11 Ciprofloxacin.................................................................................................................................... 72
6.12 Cloxacillin......................................................................................................................................... 76
6.13 Didanosine....................................................................................................................................... 80
6.14 Erythromycin (as free base and stearate)........................................................................................... 84
6.15 Ethambutol*..................................................................................................................................... 88
6.16 Furosemide....................................................................................................................................... 92
6.17 Glibenclamide.................................................................................................................................. 96
6.18 Griseofulvin.................................................................................................................................... 100
6.19 Indinavir......................................................................................................................................... 104
6.20 Isoniazid*........................................................................................................................................ 108
6.21 Lamivudine*................................................................................................................................... 112
6.22 Lumefantrine*................................................................................................................................ 116
6.23 Mebendazole.................................................................................................................................. 120
6.24 Mefloquine..................................................................................................................................... 124
6.25 Metronidazole................................................................................................................................ 128
6.26 Nevirapine*.................................................................................................................................... 132
6.27 Oseltamivir..................................................................................................................................... 136
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A Concise Quality Control Guide on Essential Drugs and other Medicines · Volume II on Thin Layer Chromatographic Tests