| Different from other common products, drugs are closely correlated with publichealth and lives because they are used to prevent, cure and diagnose the disease ofhuman. Safe and effective drugs can cure or reduce the symptoms of an illness.However, counterfeit drugs can delay the illness or kill patients. Pharmaceuticalcounterfeiting is becoming a serious problem in the world, especially in developingcountries including China. Combating counterfeit drugs is very significant for drugadministration.With the support of Chinese State Food and Drug Administration (SFDA), theproject of screening counterfeit drugs was developed by the National Institute for theControl of Pharmaceutical and Biological Products of China (NICPBP). The studyprogram in this dissertation belonged to the project and contained two parts. In thefirst part, rapid determination system of high performance liquid chromatography(HPLC) was studied for screening counterfeit drugs. In the second part, theenvironmental protection HPLC instrument was developed.In the first part, clinical commonly used chemical drugs classified according totheir pharmacological functions were regarded as our research objects. Rapiddetermination HPLC system which was composed of identification system andquantitation system was developed using C18 column. Rapid determination systemsof eight categories (61 drugs) have been established, such as adrenal cortex hormones,sex hormones, sulfanilamides, anti-diabetic drugs, calcium antagonists, lipid regulator,anti-AIDS drugs, anti-malarial drugs. Simple chromatographic system such asisocratic mobile phase of acetonitrile-water, methanol-water, methanol-buffer andultraviolet detector were used in these systems. Most components of each categorycould be separated simultaneously on one chromatographic system and the resolutionwas also suitable for identification. The methodologies of 23 drugs were completed.All the results showed good precision and accuracy, which were suitable for quantitation analysis. The rapid screening methods of six kinds of drugs have beenpassed by local institutes of drug control in China. The drugs and dietary supplementsamples purchased from current market were screened and six of them werecounterfeit.Environmental protection HPLC was developed in the second part for screeningcounterfeit drugs in the spot. To be different from the normal HPLC, this instrumenthad a recycling obturator which was suitable for isocratic mobile phase. Savingmobile phase and decrease waste liquid were its advantages. Feasibility was evaluatedby chromatographic parameters of different mobile phases. The relative standarddeviation of retention time and area were lower than the regulated value of ChinaPharmacopoeia and the environmental protection HPLC could be used for assay ofsamples. All these proved that it was economical, stable and feasible. Furthermore, theenvironmental protection HPLC was improved to become mobile HPLC, whichwould satisfy instant analysis on the spot.Rapid determination system of HPLC was specificity, simple, rapid androbustness, which could be used in undeveloped areas and local institutes of drugcontrol. The environmental protection HPLC was economical, accurate and lesseningthe pollution. All these will be in favor of screening counterfeit drugs.
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