Investigation of Materials and Methods for Pharmacopoeial Metrology
Main researcher
: GRDINIĆ, VLADIMIR (14312) Assistants
PERIĆ-BARBARIĆ, MIRJANA (178050)
STAREŠINIĆ-ŠENHORST, IVANA (177824)
CETINA-ČIŽMEK, BISERKA (121030)
DURRIGL, ANTUN (113494)
JAKŠEVAC, MAJA (17861)
LUTEROTTI, SVJETLANA (26936)
BEZJAK, ALEKSANDAR (3466)
Type of research: applied Duration from: 01/01/91. Papers on project (total): 83
Papers on project quoted in Current Contents: 11
Institution name: Farmaceutsko-biokemijski fakultet, Zagreb (6) Department/Institute: Department of Analytics and Quality Control of Medicines Address: A. Kovačića 1
Communication
Phone: 385 (0)41 445134
Phone: 385 (0)1 4550398
Summary: Applied investigation for the development of pharmacopoeial
metrology is performed. This investigation contains an unroundaboud part of
basic research activities on which a teoretical concept and an evolution of
modern methodological principals in the analysis of pharmaceutical
substances and pharmaceutical dosage forms as well as in preparation of
chemical reference substances is constructed. Some guidelines is offered
regarding approaches to the generation of the varied materials required for
analytical quality control, particularly for pharmacopoeias and quality
control of medicines. Major investigations in such endeavour are the goal
of the undertaking and role of the final product, selection of candidate
analytical procedures, their matematical-statistical verificatio by
Gottschalk' standardization, then preparation, characterization and
certification of materials, also making relevant software packets. The
approach to chemical and physical characterization relies on the
measurement philosophy, selection of analyte, their speciation, and
selection of analytical methods for establishment of quality and
quantitative levels. With the view to attempting to fill some of the gaps
in the Croatian repertoire of reference materials and to have suitable
product for laboratories' use, preparation has been completed of twelve
reference materials for correction and control melting point, and
azithromycin (polymorph A) for identity tests and assay. Finally, the
"Dictionary of Metrology" which contains about 500 entries of scientific
terms in common use in quality control of medicine, and the manual
"Pharmacopoeial Nomenclature: Proposal for Croatian Linguistic Norm and
Codification in Pharmacopoeia" was prepared.
Keywords: pharmacopoeia, reference materials, good measurement practices, good analytical practices, pharmaceutical analysis, software packet, performance testing, purity test, standardization, drug substances, differential scanning calorimetry, spectroscopy, melting point determination, azithromycin, chemometrics
Research goals: Goals of investigation are: 1. determination of
methodology for the preparation of reference materials; 2. guidance for
the evaluation of procedures in analytics and control of medicines; 3.
development os software packets as a tool in pharmaceutical analysis;
4. contributions for construction and development of Croatian
Pharmacopoeia; 5. preparation of relevant chemical reference
substances. Results of investigation are as follows: 1. the methodology
is established for the preparation of reference substances as the starting
point in investigations; 2. phase solubility analysis and differential
scanning calorimetry, particularly in sense of purity determination of the
pharmaceutical substances were studied; 3. algorithm for evaluation of
procedure in analytics and control of medicines is defined and
corresponding mathematic-statistical model on the some quantitative
analytical procedures are applied; 4. contributions in the field of
good analytical practices, pharmacopoeia, metrology, and analytical
chemistry are given, especially by certain procedures for identity and
assay of analyte, for quality control of medicines, and for identification
of powdered vegetable drugs on the base of microchemical procedures and
microscopical search; 5. software packets for: evaluation of analytical
procedure (ESKULAP), identification of powdered vegetable drugs (MIKROID),
purity determination by differential scanning calorimetry (DSCOUT) and
phase solubility analysis (FAZAN), ruggedness test (RUGGMET), and analysis
of laboratory test results (INTFAR) were made; and 6. 13 new materials
from the order of chemical reference substances needful for national
metrology: azobenzene, vanillin, benzil, acetanilide, phenacetin,
benzanilide, sulfanilamide, sulfaguanidine, dicyandiamide, saccharin,
caffeine, phenolphthalein, and azithromycin were made. Other information about the project.