Combining simplicity with cost-effectiveness: Investigation of potential counterfeit of proton pump inhibitors through simulated formulations using thin-layer chromatography.
A simple, accurate and precise high-performance thin-layer chromatographic method has been developed and validated for the analysis of proton pump inhibitors (PPIs) and their co-formulated drugs, available as binary combination. Planar chromatographic separation was achieved using a single mobile phase comprising of toluene: iso-propranol: acetone: ammonia 5.0:2.3:2.5:0.2 (v/v/v/v) for the analysis of 14 analytes on aluminium-backed layer of silica gel 60 FG254. Densitometric determination of the separated spots was done at 290nm. The method was validated according to ICH guidelines for linearity, precision and accuracy, sensitivity, specificity and robustness. The method showed good linear response for the selected drugs as indicated by the high values of correlation coefficients (≥0.9993). The limit of detection and limit of quantiation were in the range of 6.9-159.2ng/band and 20.8-478.1ng/band respectively for all the analytes. The optimized conditions afforded adequate resolution of each PPI from their co-formulated drugs and provided unambiguous identification of the co-formulated drugs from their homologous retardation factors (hRf). The only limitation of the method was the inability to separate two PPIs, rabeprazole and lansoprazole from each other. Nevertheless, it is proposed that peak spectra recording and comparison with standard drug spot can be a viable option for assignment of TLC spots. The method performance was assessed by analyzing different laboratory simulated mixtures and some marketed formulations of the selected drugs. The developed method was successfully used to investigate potential counterfeit of PPIs through a series of simulated formulations with good accuracy and precision.
Department of Chemistry, School of Sciences, Gujarat University, Ahmedabad 380009, Gujarat, India.
Nejal M
NM
Bhatt
Department of Chemistry, School of Sciences, Gujarat University, Ahmedabad 380009, Gujarat, India.
Vijay D
VD
Chavada
Department of Chemistry, St. Xavier's College, Navrangpura, Ahmedabad 380009, Gujarat, India.
Mallika
M
Sanyal
Department of Chemistry, School of Sciences, Gujarat University, Ahmedabad 380009, Gujarat, India. Electronic address: pranav_shrivastav@yahoo.com.
Pranav S
PS
Shrivastav
D002626:Chemistry, Pharmaceutical; D002855:Chromatography, Thin Layer / Q000191:economics* / Q000379:methods*; D003365:Costs and Cost Analysis; D058110:Counterfeit Drugs / Q000032:analysis* / Q000737:chemistry; D003720:Densitometry; D064747:Lansoprazole / Q000032:analysis; D057230:Limit of Detection; D054328:Proton Pump Inhibitors / Q000032:analysis* / Q000737:chemistry; D064750:Rabeprazole / Q000032:analysis
D058110:Counterfeit Drugs; D054328:Proton Pump Inhibitors; D064747:Lansoprazole; D064750:Rabeprazole
Cost-effectiveness; Counterfeit analysis; Pharmaceutical analysis; Proton pump inhibitors; Thin layer chromatography