High-Performance Thin-Layer Chromatography for the Simultaneous Determination of Co-administrated Granisetron, Aprepitant, and Deflazacort Used with Chemotherapy: Application onto Dosage Forms and Spiked Plasma by Liquid-Liquid Extraction

摘要

A selective and economic high-performance thin-layer chromatography (HPTLC) method has been developed for the simultaneous determination of the co-administrated drugs, namely, granisetron, aprepitant, and deflazacort, used with chemotherapy. Granisetron, aprepitant, and deflazacort were chromatographed on HPTLC silica gel 60 F-254 plates using chloroform. methanol. formic acid (18:1.5:1, v/v) as the developing system at R-F values of 0.12 +/- 0.06, 0.45 +/- 0.02, and 0.58 +/- 0.05, respectively. Densitometric measurements were carried out using a CAMAG TLC Scanner 3 at 220 nm. The cited method was applied for the analysis of granisetron, aprepitant, and defl azacort in a binomial relationship over a concentration range of 0.1-2, 0.2-4, and 0.1-2 mu g per band, respectively. The limits of detection were found to be 0.027 mu g per band for granisetron, 0.048 mu g per band for aprepitant, and 0.031 mu g per band for defl azacort. Method validation as per the International Conference on Harmonization (ICH) guidelines demonstrated the selectivity, sensitivity, accuracy, precision, and robustness of the method. The developed HPTLC method was found to be applicable to the dosage forms of the selected drugs with good recoveries and thus can be used for routine analysis in quality control laboratories. The cited HPTLC method was successfully applied for the detection and determination of the selected drugs in spiked plasma by liquid-liquid extraction using a mixture of dichloromethane and tert-butyl methyl ether (4:1, v/v). Moreover, statistical analysis of the results was performed revealing accuracy and precision.