Table 4.
Thin-layer chromatography | ||||||
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|
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Generic name | Manufacturer | Batch number | Tested n |
Retention factor error* % |
API content† % |
Failed n |
Isoniazid | PhC Romat | 010113 | 16 | 0–1.52 | 100 | 0 |
020113 | ||||||
290213 | ||||||
190213 | ||||||
Rifampicin | PhC Romat | 50212, 401212, 30113, 30212, 20112, 340913, 300613 | 28 | 0–0.23 | <80 | 28 |
20113, 220513, 361212 | 12 | 0 | <80 | 0 | ||
Ethambutol | Macleods | FEL 105A | 12 | 0 | 100 | 0 |
FEL 107A | ||||||
FEL 108A | ||||||
Ethambutol | Lupin | BL10018 | 4 | 0 | <80 | 4 |
Rifampicin | Brinsalov-A | 170413, 40113 110213, 591214 | 16 | 0 | 100 | 0 |
Pyrazinamide | Lupin | DN20021, DN20022, DN10026, DN10036, DN10027, DN20028 DN20010A | 28 | 0–0.93 | 80–100 | 0 |
Ethionamide | Lupin | CH 20002 A | 4 | 0 | 100 | 0 |
Prothionamide | Lupin | A300429, A300438, A300439, A300346 DN28030 | 20 | 0 | 100 | 0 |
Cycloserine | Global Pharm | 30113, 521212, 220513,190513 | 16 | 0 | 100 | 0 |
Kanamycin | Santo | 20313 | 4 | 1.28 | <80 | 4 |
10113, 10212 | 8 | 0 | 80–100 | 0 | ||
Ofloxacin | Global Pharm | 40112 | 4 | 1.79 | 100 | 0 |
Levofloxacin | Chimfarm | 160712, 70512 | 8 | 0–0.88 | 100 | 0 |
Moxifloxacin | MSN Laboratories | 41302200, 41301212 | 8 | 0 | 100 | 0 |
Amoxicillin, clavulanic acid‡ | Unichem Laboratories | BMVM12051 BMVM13020 BMVM13005 | 24 | 0 | 100 | 0 |
Total | 212 | 36 |
Relative retention factors of the spot with that of the standard to identify the presence of the API (should be ≤5%).
Should be 80–100%.
Amoxicillin and clavulanic acid samples/batch tested separately.
API = active pharmaceutical ingredient.