306
Volume 5, Issue 10: Special Issue
(EJAR)
ISSN: 2181-2020
MPHAPP
THE 6TH INTERNATIONAL SCIENTIFIC AND PRACTICAL
CONFERENCE
“
MODERN PHARMACEUTICS: ACTUAL
PROBLEMS AND PROSPECTS
”
TASHKENT, OCTOBER 17, 2025
in-academy.uz
DETERMINATION OF STABILITY OF THE COMBINED HEPATOPROTECTIVE
DRUG “HEPATON”
Zhuraeva M.A.
Aglokhodjayeva Sh.M.
Tashpulatova A.D.
Tashkent Pharmaceutical Institute, Tashkent city, Republic of Uzbekistan
https://doi.org/10.5281/zenodo.17335366
Relevance of the study:
Stability is one of the key criteria of the quality of medicinal products,
determining their effectiveness, safety, and shelf life. It is especially critical to take this parameter
into account in the development and production of infusion solutions, since they are administered
directly into the systemic bloodstream, bypassing the protective barriers of the div. This means that
any changes in the composition or properties of such solutions can immediately affect the patient’s
condition. In this regard, infusion preparations must have a high degree of physicochemical stability
and strictly comply with a number of parameters close to physiological ones: osmolarity, pH level,
transparency, viscosity, and sterility.
The stability of combined infusion solutions is not just a pharmaceutical indicator but a
critically important factor determining both the quality of the drug itself and its clinical applicability.
Conducting comprehensive stability studies at all stages — from development to storage — is a
necessary condition for guaranteeing the safety and effectiveness of therapy with such dosage forms.
Purpose of the study:
To investigate the influence of different storage conditions on the
stability and to determine the shelf life of the infusion solution “Hepaton”.
Materials and Methods:
In the course of the study, two methods were used to determine
stability: the method of natural storage and the accelerated aging method according to the Temporary
Instruction И-42-2-82. As research objects, 5 series of laboratory samples of the infusion solution
“Hepaton” were used.
The study employed solvents, reagents, and consumables from MERCK (Germany), as well as
ready-made nutrient media from HIMEDIA Laboratories Pvt. Ltd (India). The following auxiliary
equipment was also used in the tests: magnetic stirrers, Sartorius BP-3105 analytical electronic
balances (Germany), HS 32 AC sterilizer with automation, Seven Easy pH meters from Mettler
Toledo (Switzerland), and 766 Calimatic Knick (Germany).
Qualitative and quantitative indicators were determined in accordance with the normative
document for the studied drug; the methods listed in the State Pharmacopoeia of the Republic of
Uzbekistan were applied. Studies under normal conditions were carried out by storing samples in the
above-mentioned packaging on laboratory shelves and cabinets at a temperature of 20 ± 2 °C. Under
natural conditions, samples were taken for analysis every six months, with quality indicators
determined each time.
Studies by the accelerated aging method were carried out according to the Temporary
Instruction И-42-2-82 at a temperature of 60 °C in an HS 32 AC thermostat. During the experiment,
samples were taken every 11.5 days, which corresponds to an equivalent storage period under normal
conditions, in accordance with the Instruction. The total duration of the experiment was 46 days.
Results:
It was established that the quality indicators remained within the limits specified in
the normative document.
307
Volume 5, Issue 10: Special Issue
(EJAR)
ISSN: 2181-2020
MPHAPP
THE 6TH INTERNATIONAL SCIENTIFIC AND PRACTICAL
CONFERENCE
“
MODERN PHARMACEUTICS: ACTUAL
PROBLEMS AND PROSPECTS
”
TASHKENT, OCTOBER 17, 2025
in-academy.uz
Conclusions:
Thus, the recommended composition and manufacturing technology, as well as
the type of packaging used, ensure the stability of the infusion solution “Hepaton” for 2 years, both
under natural storage conditions and by the accelerated aging method.
