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EN
Transfer of six thin-layer chromatography (TLC) Global Pharma Health Fund Minilab kit protocols for detecting fake or markedly substandard drugs in pharmaceutical products in the field to quantitative high-performance TLC (HPTLC)–densitometry methods was carried out using a model process published earlier. The developed and validated methods for tablets or capsules containing cefixime, cefuroxime axetil, cephalexin•H2O, ciprofloxacin HCl, levofloxacin, and metronidazole involved use of EMD Millipore Premium Purity silica gel 60 F254 plates, automated sample and standard solution application with a CAMAG Linomat 4, and automated densitometry with a CAMAG Scanner 3 for detection, identification, and quantification.
EN
A simple, specific, accurate, and precise high-performance thin-layer chromatographic method for analysis of cefuroxime axetil and potassium clavulanate in a combined tablet dosage form is reported. The compounds were separated on aluminium foil plates precoated with silica gel 60 F 254 , with chloroform-methanol-toluene 4:3:3 ( v / v ) as mobile phase. Densitometric evaluation of the separated bands was performed at 225 nm. The two drugs were satisfactorily separated with R F 0.77 ± 0.0114 and 0.29 ± 0.0114 for cefuroxime axetil and potassium clavulanate, respectively. Response was a linear function of amount over the calibration ranges 500–2500 and 2000–10 000 ng per band, respectively. The method was successfully validated and used for analysis of the drugs in a pharmaceutical formulation. Recovery was 100.05 ± 0.98% for cefuroxime axetil and 99.94 ± 0.538% for potassium clavulanate (mean ± RSD).
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