Levashova O. Development and validation of quality control methods of multivitamin and mineral agents.

Українська версія

Thesis for the degree of Candidate of Sciences (CSc)

State registration number

0411U006259

Applicant for

Specialization

  • 15.00.03 - Стандартизація та організація виробництва лікарських засобів

06-10-2011

Specialized Academic Board

Д 64.605.01

National University of Pharmacy

Essay

For the first time it was elaborated acceptance criteria for the validation characteristic with the respect to the requirements for the uncertainty of analytical method of quantitative determination of microelements by atomic absorption spectrometry using calibration curve. Methods of quantitative determination of microelements in multivitamin and mineral complexes were developed and validated. The algorithm of determination is offered in the gradient mode for water-soluble vitamins and in isocratic for oil-soluble vitamins by the high-performance liquid chromatography method. The results of the validation confirmed that the techniques are responsible for their purpose with respect to determining the quality of multivitamin and mineral agents.

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