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

Abstract

Transfer of thin-layer chromatography Global Pharma Health Fund Minilab kit protocols for detecting counterfeit drugs in pharmaceutical products in the field to quantitative high-performance TLC (HPTLC)-densitometry methods was carried out for potassium clavulanate and metformin HCl using a model process published earlier. HPTLC-densitometry methods were also developed following the model process for caffeine, fluoxetine HCl, and gabapentin, for which methods are not included in the Minilab manual. The model process involves 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 determination of peak purity and identification and for quantification. Detection methods for counterfeit samples of the three drugs not covered in the Minilab manual were also developed and posted online with open access as supplemental methods for the Compendium of Unofficial Methods for Rapid Screening of Pharmaceuticals by Thin Layer Chromatography.