QUANTITATIVE DETERMINATION OF POLYHEXAMETHYLENE GUANIDINE HYDROCHLORIDE IN A COMBINED PHARMACEUTICAL FORMULATION

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 e-mail: [email protected] 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.