الفهرس | Only 14 pages are availabe for public view |
Abstract Isocratic reversed-phase high-performance liquid chromatographic methods have been developed and validated for simultaneous determination certain drugs in their laboratory prepared mixtures and pharmaceutical dosage forms focusing on counterfeit. These methods were used to detect counterfeited drugs in pharmaceutical products sold in Yemen and traditional herbal medicines sold in India and China. The studied drugs include antiplatelet drugs (aspirin, clopidogrel bisulfate, andprasugrelHCl), anti-hyperlipidemia drugs (nicotinic acid, rosuvastatin calcium, pravastatin sodium, atorvastatin calcium, lovastatin sodium, pitavastatin calcium and simvastatin sodium) and anti-diabetic drugs (metformin HCl, saxagliptin, vildagliptin,alogliptin benzoate, linagliptin, and sitagliptin phosphate monohydrate). Thin-layer chromatography and mass spectrometry with or without nuclear magnetic resonance were also applied to counterfeit herbal medicines to verify the identification of adulterants. The methodology of experimental designs, Plackett-Burman and Box-Behnken designs have been used to screen and optimize the composition of the mobile phase. The methods validation has also been performed following the guidelines of International Council on Harmonization (ICH). The developed methods for routine analysis were simple, sensitive, accurate, economical and highly robust. The results have beencompared statistically to reference methods applying Student’s t-test and variance ratio F-test at p < 0.05 |