Pharmaceutical Analysis II

Drug control is a pharmaceutical discipline of principal importance. Both theoretical and practical education aims to instruct how to assure the quality, safety and efficacy of drugs, which fulfils one of the basic tasks of pharmaceutical studies. Education is conceived in such a way as to be in line not only with the current valid Czech Pharmacopoeia, but with other modern pharmacopoeial monographs as well. The structure of a chemical drug is the starting point for the determination of a suitable procedure for identification and quantitative analysis. Emphasis is also laid on control analytical methods from the standpoint of detection of accompanying impurities and stability of drugs. Education incorporates requirements for drug quality in connection with the guidelines of Good Laboratory Practice and Good Manufacturing Practice. In the course of a two-semester training in practical classes, every student has access to the Pharmacopoeia in order to be able to get quickly oriented in a considerable amount of factual data. Control of chemical drugs is a component of the comprehensive State Final Examination in the fifth year and the topics are selected in such a way as to cover the important areas of the field. University textbooks written at the Department of Pharmaceutical Chemistry and Drug Control have been conceived in such a way as to be helpful also for the specialist in pharmaceutical practice working in the field of control-analytical and bioanalytical evaluation of drugs.

Syllabus

Lectures

Structure of the drug as the starting point for the determination of analytically usable physicochemical properties

Drug Identification

  • Detection of drugs on the basis of physical constants (melting point, distillation range, density, refractive index, optical rotation)
  • Use of physicochemical methods for the detection of drugs (spectral, separational, electrochemical methods)
  • Detection of drugs by means of chemical reactions
  • Group and selective reactions of individual structural types of drugs of important pharmacotherapeutic groups (analgesics-antipyretics, analgesics-anodynes, sedatives, anaesthetics, hypnotics, psychopharmaceuticals, analeptics, local anaesthetics, myorelaxants, adrenomimetics, adrenolytics, cholinomimetics, cholinolytics, antihistamines, cardiotonic glycosides, antihypertensives, vasodilators, laxatives, diuretics, vitamins, hormones, antimycotics, antimalarial agents, antibacterial sulfonamides, antibiotics, antiviral agents, anthelminthic agents)

Drug Assay

  • Volumetric methods used in pharmacopoeial drug control
  • Acid-base titrations of drugs (acidimetry, alkalimetry in aqueous and nonaqueous media)
  • Oxidoreduction titrations of drugs (iodometry, bromatometry, manganometry, cerimetry)
  • Complexometric titrations of drugs (chelatometry, mercurimetry)
  • Determination of drugs by means of precipitation titrations
  • Spectrophotometric determination of drugs
  • Polarimetric determination of drugs
  • Determination of drugs with the use of electroanalytical methods
  • Determination of drugs by chromatographic and electrophoretic methods

Purity and stability of drugs

  • Pharmacopoeial detection of impurities with the use of chemical reactions by means of physicochemical methods
  • Stability of drugs, processes of decomposition, factors influencing stability
  • Accelerated stability tests, calculation of kinetic characteristics of decomposition reactions
  • Knowledge of chemism of decomposition reactions as the prerequisite of stabilizing interventions

The fundamentals of drug level monitoring

The principles of good laboratory practice

Practical Training

  • Control-analytical evaluation of drugs according to the pharmacopoeia
  • Identification of drugs by means of physical constants, chemical reactions, physicochemical methods
  • Test for purity of drugs (chemical detection of impurities, detection of impurities, or degradation products by chromatographic and spectral methods)
  • Determination of drug content (pharmacopoeial methods of quantitative evaluation of drugs)
  • Control-analytical evaluation of pharmaceutical preparations
  • Control of extemporaneously prepared pharmaceutical preparations according to the pharamacopoeia and control-analytical procedures used in drug control laboratories
  • Control of mass-produced pharmaceutical preparations according to factory standards (control- analytical methods used in outlet control in pharmaceutical industry)
  • Semidemonstrative tasks (use of UV spectrometry in drug control, use of IR spectrometry in drug control, analysis of drugs on the basis of specific optical rotation, analysis of drugs by means of HPLC, monitoring of drugs and metabolites in blood plasma by means of HPLC and TLC)

Literature

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