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

Abstract

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.

Development of Quantitative HPTLC-Densitometry Methods Following a Model Approach for Transfer of TLC Screening Methods for Pharmaceutical Products of Metformin HCL, Potassium Clavulanate, Caffeine, Fluoxetine HCL, and Gabapentin

“…Detailed HPTLC-densitometry methods and instruments were described earlier [1][2][3][6][7][8][9][10][11][12]. Silica gel 60 F 254 Premium Purity HPTLC glass plates (20 x10 cm; EMD Millipore Corp., Billerica, MA, a division of Merck KGaA, Darmstadt, Germany; Part No.…”

“…(GPHF) Minilab manual [4] or U.S. Food and Drug Administration Compendium of Unofficial Methods for Rapid Screening of Pharmaceuticals by Thin Layer Chromatography [5] to quantitative highperformance TLC (HPTLC)-densitometry methods. The model process was applied earlier to formulations containing acetylsalicylic acid, acetaminophen, ibuprofen, and chlorpheniramine maleate [1]; mebendazole, diphenhydramine HCl, amodiaquine, and artesunate [2]; amodiaqine and diazepam [3]; lumefantrine + artemether [6]; albendazole, amodiaquine + artesunate [7]; pyrazinamide + ethambutol + isoniazid + rifampicin [8]; quinine sulfate, mefloquine, and dihydroartemisinin + piperaquine phosphate [9]; azithromycin, imipramine HCl, and sulfadoxine + pyrimethamine [10]; clarithromycin, azithromycin, and amodiaquine + artesunate [11]; and cefixime, cefuroxime axetil, cephalexin hydrate, ciprofloxacin HCl, levofloxacin, and metronidazole [12].…”

Stability of Metronidazole and Its Complexes with Silver(I) Salts under Various Stress Conditions

“…The HPLC method with a gradient elution system and detection at 242 nm was also used to determine MTZ in the presence of other drugs (diloxanide, spiramycin, clioquinol) in tablets [20]. Thin layer chromatography (TLC) was used in the study of MTZ in mixtures with chemotherapeutic drugs and antibiotics, using TLC 60F 254 silica gel plates and various mobile phases [4,[21][22][23]. The assay of MTZ beside clotrimazole, mebeverine hydrochloride, and diloxanide furoate with densitometric detection has also been described [24,25].…”

Transfer of TLC screening methods to quantitative HPTLC–densitometry methods for pharmaceutical products containing amlodipine besylate, cefpodoxime proxetil, cetirizine 2HCl, diclofenac sodium, efavirenz, mefenamic acid, and atovaquone + proguanil HCl

“…(GPHF) Minilab manual [4] to quantitative high-performance TLC (HPTLC)-densitometry methods. An earlier study in the literature [5] described the application of this model process to antimicrobial and antituberculosis products containing cefixime, cefuroxime axetil, cephalexin•H 2 O, ciprofloxacin HCl, levofloxacin, and metronidazole. In this article, the application of the transfer process is extended by seven products containing eight important drugs of different types: amlodipine besylate (calcium channel blocker, CAS No.…”

“…637-32-1). In addition, two previously transferred HPTLC-densitometry methods for the antibiotics azithromycin dihydrate [6] and cephalexin [5] were successfully applied to analyze a new product of each drug to demonstrate their applicability.…”