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Development of quantitative HPTLC–densitometry methods following a model approach for transfer of TLC screening methods for pharmaceutical products of cefixime, cefuroxime axetil, cephalexin⋅H2O, ciprofloxacin HCl, levofloxacin, and metronidazole

Zhang D., Armour E., Sherma J.

Acta Chromatographica

2017

Vol. 29, no. 4

484--486

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.

Mathematic Simulating of Levofloxacin Release from Chitosan Nano/Microparticles

Guan J., Cheng P., Huang S., Li Z., Wu J., Gao P., Wang X., Zhang H.

Przegląd Elektrotechniczny

2012

R. 88, nr 7b

345--349

Chitosan based levofloxacin nano/microparticles were prepared by ionotropic gelatin and emulsion crosslinking technique. Their in vitro release profiles showed that microparticles had better sustaining delivery property than nanoparticles. The best fitting kinetics for nanoparticles and microparticles were First Order and Diffusion-Relaxation model respectively. The result suggests that levofloxacin delivery from nanoparticles was mainly controlled by diffusion process only, and that from microparticles was dominated by both diffusion and relaxation process.

Mikro- i nanoelementy lekarstwa levofloaxin były wytwarzane techniką sieciowania emulsji. Dla lepszego dopasowania kinematyki opracowano model matematyczny. Stwierdzono że nanocząstki dostarczają materiał przez dyfuzję podczas gdy mikrocząstki wykorzystują też relaksację.

A validated stability-indicating isocratic LC method for levofloxacin in the presence of degradation products and its process-related impurities

Sateesh J. N., Subba Reedy G. V., Jayaveera K. N., Dhayalamurthi S

Acta Chromatographica

2012

Vol. 24, no. 1

23--36

The objective of the current study is to develop a validated specific stability-indicating isocratic reversed-phase liquid chromatographic method for the quantitative determination of levofloxacin and its related substances in pharmaceutical dosage forms in the presence of degradation products and its process-related impurities. Forced degradation studies were performed on levofloxacin as per the International Conference on Harmonisation (ICH)-prescribed stress conditions using acid, base, oxidative, water hydrolysis, thermal stress and photolytic degradation to show the stability-indicating power of the method. Significant degradation was observed during oxidative stress; minor degradation was observed in acidic stress and no degradation was observed in other stress conditions. The chromatographic method was optimized using the samples generated from forced degradation studies and the spiked impurity solution. The analysis was carried out with a 50 mm length × 4.6 mm i.d., 3.0 μm particle size YMC Pack Pro-C18 column using the mobile phase consisting of a mixture of 1.0% (v/v) triethylamine in water with pH adjusted to 6.30, using orthophosphoric acid, methanol and acetonitrile (7.7:1.3:1.0) pumped at a flow rate of 0.8 mL min−1 with ultraviolet (UV) detection at 235 nm. The limit of detection and the limit of quantification for the levofloxacin and its process-related impurities were established. The stressed test solutions were assayed against the qualified working standard of levofloxacin and the mass balance in each case was in between 99.1% and 99.9%, indicating that the developed liquid chromatography (LC) method was a stability-indicating technique. Validation of the developed LC method was carried out as per ICH requirements.