РОЗРОБКА МЕТОДИКИ КІЛЬКІСНОГО ВИЗНАЧЕННЯ ДЛЯ ПОСТАДІЙНОГО КОНТРОЛЮ ВИРОБНИЦТВА ТАБЛЕТОК «ГІПЕРТРИЛ»

Анотація

L.I.Kucherenko, N.V.Parnyuk, Z.B.Moryak

DEVELOPMENT OF QUANTITATIVE DETERMINATION METODS FOR THE STEPWISE CONTROL OF "HYPERTRIL" TABLETS PRODUCTION

Zaporizhzhia State Medical University

“Pharmatron” Scientific-and-Production Corporation

Key words: hypertril, tablet mass, tablets, spectrophotometry

Introduction

Last 20-25 years inUkraineare characterized by unfavorable demographic situation, a significant increase in morbidity and mortality. The deterioration ofUkrainepopulation health is often caused by cardiovascular diseases. Therefore, the development of treatments for diseases of the cardiovascular system is the actual problem of modern medicine and pharmacy. This led to the creation of fundamentally new antianginal and antihypertensive medication of original structure, which will have a minimum of side effects. At the Department of Pharmaceutical Chemistry of Zaporizhzhia State Medical University in collaboration with the SPC "Pharmatron" under the direction of Professor Mazur I.A, a new original compound - bromide 1-β-phenylethyl-4-amino-1,2,4-triazole (hypertril) is received and shows antihypertensive, antiischemic and antioxidant properties. Most drugs for the treatment of cardiovascular disease are used in pill form. Therefore, the new elected rational drug dosage form is a pill.

The aim of  research

Development of methods of standardization, in particular quantitative content of hypertril in tablet weight by physical and chemical methods.

Materials and methods

During technological research a drug (pill average weight0.15 grams) containing0.02 gof active substance, was developed. During the stepwise control of pill's production the greatest attention is paid to quality control of tablet weight. One of the most modern methods of pharmaceutical analysis is instrumental methods, including spectral one.

Results and discussion

During previous studies, we have developed a method of spectrophotometric determination of hypertril substance. The studies showed that the absorption curves in the UV region of our and standard designs are identical and absorption maxima coincide. For the qualitative and quantitative determination of hypertril in tablet weight, a spectrophotometric determination method was approbated. Also it was developed and used to standardize hypertril substance.

Identification of the substance in hypertril tablet weight by spectrophotometry.

We measure the optical spissitude of the prepared solution of hypertril tablet weight.

Preparation of standard solution (comparison solution). We measure the optical spissitude of the standard sample at a wavelength λ = 258 nm. As a standard substance we use hypertril sample (state owned enterprise "Plant of chemical reagent" of Science and Technology Complex "Institute for Single Crystals " NAS of Ukraine), which meets the requirements of quality control methods. Terms of spectrophotometric determination.

Optical spissitude measurement of solutions was held by scanning spectrophotometer Optizen POP, relatively solvent water, the thickness of the cuvette -1 cm, wavelength λ = 258 nm. As a result of our research the methodology of standardization of hypertril in tablet weight was designed by spectrophotometry method that is simple and easy in execution, replicable and meets all the requirements of the State Pharmacopoeia and international standards.

Findings

As a result of research, we developed a sensitive, objective, reliable and reproducible method for the spectrophotometric determination of hypertril in the tablet mass.

References

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