Abstract
According to the EP monograph "Sodium hyaluronate" for identification they use the infrared transmission spectrum of the substance, quantification is carried out by spectrophotometry. The aim of the work was to develop a method for quantitative determination of hyaluronic acid in the gel in the presence of other substances and its validation. Materials and Methods. The object of the study were samples of combined dental gel of the following composition: metronidazole benzoate 16 mg/g, miramistin 5 mg / g, sodium hyaluronate 2 mg / g. Identification and quantification of sodium hyaluronate was performed by liquid chromatography (SPhU, 2.2.29, 2.2.46). The test solution and the reference solution were chromatographed, obtaining the number of parallel chromatograms not less than when checking the suitability of the chromatographic system. Chromatography is performed on a liquid chromatograph with a diode-matrix detector under the following conditions: chromatographic column PL-aquagel-OH, Agilent size 300 mm × 7.5 mm, with a particle size of sorbent 8 μm; mobile phase A: 0.1 M sodium sulfate solution; mobile phase B: acetonitrile for chromatography P; detection at a wavelength of 210 nm. Results. The retention time of sodium hyaluronate on the chromatogram of the test sample of the gel coincides with the peak and the retention time on the chromatogram of the comparison solution of the standard sample of the substance. The suitability of the chromatographic system for 3 parallel determinations was checked: the relative standard deviation (RSD) is equal to 0.25, the number of theoretical plates is 980, the symmetry coefficient is 1.293. The validation characteristics of the developed methodology meet the established eligibility criteria. The spectral purity coefficients (Fp) of the sodium hyaluronate peak on the chromatograms of the model solution are Fp1=997.665 and Fp2=997,802. The method is linear in the range of sodium concentration of hyaluronate 80–120 %, the calculated linear dependence of the reduced area of the chromatographic peak on the reduced concentration of sodium hyaluronate is |a|=1.9490≤Δa=2.56. The confidence interval of the unit value for the sample of relations is found / entered Δz=1.08, which corresponds to the condition Δz≤1.6 %. The value of the systematic error is equal to δ=0.12, which satisfies the condition δ≤0.51 %. Conclusions. The method of quantitative determination of sodium hyaluronate by the method of high-performance liquid chromatography has been developed and investigated. The method allows the identification and quantification of sodium hyaluronate in the composition of the dental gel, in the presence of metronidazole benzoate and miramistin. Validation of the methodology was performed and the main validation characteristics were determined. In terms of specificity, linearity, correctness, convergence of the method meets the eligibility criteria established by the SPhU.
Highlights
Hyaluronic acid (HA) is a key element in the soft tissues of the periodontium and periodontal ligament, as well as in hard tissue such as alveolar bone, and performs many structural and physiological functions in these tissues [1].Today HA is widely used in many branches of medicine with interesting potential applications in dentistry for the treatment of acute and chronic inflammatory disease
Data obtained from the present review of 20 clinical studies demonstrate that, due to its positive action on tissue repair and wound healing, topical administration of HA could play a role in postoperative dental surgery, and in the treatment of patients affected by gingivitis and periodontitis, with a significant improvement in their quality of life [2, 3]
Our studies have shown that the method of absorption spectrophotometry does not allow a reliable quantitative assessment of the content of hyaluronic acid in the presence of other components of the drug, in particular metronidazole benzoate [12]
Summary
Hyaluronic acid (HA) is a key element in the soft tissues of the periodontium and periodontal ligament, as well as in hard tissue such as alveolar bone, and performs many structural and physiological functions in these tissues [1].Today HA is widely used in many branches of medicine with interesting potential applications in dentistry for the treatment of acute and chronic inflammatory disease. Hyaluronic acid is used as a single drug in the form of solutions, gels, injectable solutions, or in combination with antibacterial, antiseptic active pharmaceutical ingredients, vitamins, etc. The object of our research is a combined dental gel that contains hyaluronic acid and two active substances with antibacterial action: metronidazole and miramistin. Hyaluronic acid is a natural unsulfated glycosaminoglycan with a high molecular weight of 4000–20000000 [1]. Identification of hyaluronic acid as an active pharmaceutical ingredient (API) is carried out by various physicochemical methods. The acidic properties of hyaluronate allow to obtain solutions in water of salts with alkali metals. Hyaluronic acid is an anionic linear polysaccharide with different molecular weight, which depends on the method of its production. The absence of isomerism, which is characteristic of most glucosaminoglycans, ensures the chemical identity of the obtained hyaluronates [9]
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