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. K a chenko
S.E. Rzheuski
Vi ebsk S a e O de o he F iendship o Peoples Medical Uni e si y, Vi ebsk ci y,
Republic o Bela us
e-mail: [email p o ec ed]
h ps://doi.o g/10.5281/zenodo.17333674
Backg ound: The de elopmen o no el an ibac e ial agen s ep esen s a p omising di ec ion
in mode n medicine. The demand o such d ugs is con inuously inc easing due o he g owing
bac e ial esis ance o exis ing an imic obial agen s. One app oach in pha maceu ical de elopmen
in ol es iden i ying combina ions o subs ances wi h an imic obial ac i i y ha demons a e
syne gis ic o addi i e e ec s. A c i ical s ep in he c ea ion o a new d ug o mula ion is he
de elopmen o an analy ical me hod o he quan i a i e de e mina ion o i s ac i e pha maceu ical
ing edien s.
Objec i e: To de elop a me hod o he quan i a i e de e mina ion o polyhexame hylene
guanidine hyd ochlo ide in a combined pha maceu ical o mula ion.
Ma e ials and Me hods: Expe imen al labo a o y ba ches o a medical oam con aining a
combina ion o polyhexame hylene guanidine hyd ochlo ide and e ame hylenediamine e amine
we e used as he es objec s. The quan i a i e con en o polyhexame hylene guanidine hyd ochlo ide
in he medical oam was de e mined by a gen ome ic i a ion using po assium ch oma e as an
indica o and 0.01 M sil e ni a e solu ion as he i an .
Resul s: S abili y es ing o he 0.01 M sil e ni a e solu ion demons a ed ha , when s o ed
p o ec ed om ligh , he solu ion emains s able o up o 20 days ( he dec ease in concen a ion by
day 20 was s a is ically insigni ican , p > 0.05). Speci ici y assessmen con i med ha he de eloped
me hod is speci ic: addi ion o a single d op o i an o he placebo solu ion immedia ely induced a
colo change, whe eas he es solu ion exhibi ed a colo change only a e addi ion o 16.8–17.3 mL
o i an .
Repea abili y es ing yielded a ela i e s anda d de ia ion (RSD) o 0.655% (accep ance
c i e ion: ≤1%). The in e media e p ecision (wi hin-labo a o y ep oducibili y) o a second analys
was 0.661%.
Accu acy es ing showed ha he eco e y o polyhexame hylene guanidine hyd ochlo ide
om he medical oam anged om 99.2% o 100.9%, wi h a mean alue o 100.1% (accep able
ange: 100 ± 1%). Consequen ly, he alida ed me hod was demons a ed o be applicable wi hin a
concen a ion ange o 70–130% o he nominal con en o polyhexame hylene guanidine
hyd ochlo ide, as i exhibi ed accep able linea i y, p ecision, and accu acy wi hin his in e al.
Conclusions: The 0.01 M sil e ni a e i an solu ion emains s able o 20 days when s o ed
in he da k. The de eloped analy ical me hod mee s all alida ion c i e ia s ipula ed by he Technical
Code o Es ablished P ac ice (TKP) and he S a e Pha macopoeia o he Republic o Bela us.
Repea abili y RSD alues we e 0.655% o he i s analys and 0.661% o he second. The accu acy
o polyhexame hylene guanidine hyd ochlo ide de e mina ion in he medical oam anged om
99.2% o 100.9%, wi h a mean o 100.1%. The me hod’s wo king ange was es ablished as 70–130%
o he nominal con en o polyhexame hylene guanidine hyd ochlo ide in he o mula ion.
