256
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
QUANTITATIVE DETERMINATION OF POLYHEXAMETHYLENE GUANIDINE
HYDROCHLORIDE IN A COMBINED PHARMACEUTICAL FORMULATION
R.V. Kravchenko
S.E. Rzheuski
Vitebsk State Order of the Friendship of Peoples Medical University, Vitebsk city,
Republic of Belarus
https://doi.org/10.5281/zenodo.17333674
Background:
The development of novel antibacterial agents represents a promising direction
in modern medicine. The demand for such drugs is continuously increasing due to the growing
bacterial resistance to existing antimicrobial agents. One approach in pharmaceutical development
involves identifying combinations of substances with antimicrobial activity that demonstrate
synergistic or additive effects. A critical step in the creation of a new drug formulation is the
development of an analytical method for the quantitative determination of its active pharmaceutical
ingredients.
Objective:
To develop a method for the quantitative determination of polyhexamethylene
guanidine hydrochloride in a combined pharmaceutical formulation.
Materials and Methods:
Experimental laboratory batches of a medical foam containing a
combination of polyhexamethylene guanidine hydrochloride and tetramethylenediaminetetramine
were used as the test objects. The quantitative content of polyhexamethylene guanidine hydrochloride
in the medical foam was determined by argentometric titration using potassium chromate as an
indicator and 0.01 M silver nitrate solution as the titrant.
Results:
Stability testing of the 0.01 M silver nitrate solution demonstrated that, when stored
protected from light, the solution remains stable for up to 20 days (the decrease in concentration by
day 20 was statistically insignificant, p > 0.05). Specificity assessment confirmed that the developed
method is specific: addition of a single drop of titrant to the placebo solution immediately induced a
color change, whereas the test solution exhibited a color change only after addition of 16.8–17.3 mL
of titrant.
Repeatability testing yielded a relative standard deviation (RSD) of 0.655% (acceptance
criterion: ≤1%). The intermediate precision (within-laboratory reproducibility) for a second analyst
was 0.661%.
Accuracy testing showed that the recovery of polyhexamethylene guanidine hydrochloride
from the medical foam ranged from 99.2% to 100.9%, with a mean value of 100.1% (acceptable
range: 100 ± 1%). Consequently, the validated method was demonstrated to be applicable within a
concentration range of 70–130% of the nominal content of polyhexamethylene guanidine
hydrochloride, as it exhibited acceptable linearity, precision, and accuracy within this interval.
Conclusions:
The 0.01 M silver nitrate titrant solution remains stable for 20 days when stored
in the dark. The developed analytical method meets all validation criteria stipulated by the Technical
Code of Established Practice (TKP) and the State Pharmacopoeia of the Republic of Belarus.
Repeatability RSD values were 0.655% for the first analyst and 0.661% for the second. The accuracy
of polyhexamethylene guanidine hydrochloride determination in the medical foam ranged from
99.2% to 100.9%, with a mean of 100.1%. The method’s working range was established as 70–130%
of the nominal content of polyhexamethylene guanidine hydrochloride in the formulation.
