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Development and validation of analytical methods for quantification of vancomycin lyophilized powder for injectable solution

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Author(s):
Patrícia Aleixa do Nascimento
Total Authors: 1
Document type: Master's Dissertation
Press: Araraquara. 2020-03-06.
Institution: Universidade Estadual Paulista (Unesp). Faculdade de Ciências Farmacêuticas. Araraquara
Defense date:
Advisor: Hérida Regina Nunes Salgado; Ana Carolina Kogawa
Abstract

The glycopeptide antibiotics are a class of antimicrobial agents that is an important alternative for the treatment of infections caused by some resistant bacterial strains. Studies found in literature relating vancomycin (first generation glycopeptide) and analytical methods show effective proposals for its quantification, however, there is a prevalence in the use of toxic solvents, that contributes to the generation of waste, that can be harmful to the environment, to the operator and reduce the half-life of the materials used in the analysis. In this way, it was proposed four new analytical methods for the quantitative analysis of vancomycin lyophilized powder for injectable solution, using High Performance Liquid Chromatography (HPLC), spectrophotometry in ultraviolet region (UV), in infrared region (IR) and the microbiological analysis using turbidimetry. The proposal of this work was to develop and validate analytical methods, aiming innovative and quickly methods, with the use of organic solvents of low toxicity, minimizing, in this way, the toxic action against the operators, as well as, the generation of waste to the environment, following the Green Analytical Chemistry principles. The qualitative analysis was performed by average weight, melting point, thin layer chromatography, UV, IR, HPLC and turbidimetry, making possible the identification of this drug in dosage form. For quantitative analysis, it was developed and validated analytical methods for quantification of vancomycin using UV (linear between50 to 150 µg/mL, precisewith relative standard deviation – RSD – up to 1.90 %, accuratewith mean recovery of 101.10 %, selectiveunder acid, alkaline, aqueous, oxidative and photolitic degradation, robustwhen variations were performed in wavelength, cubette volumn, filtration, monobasic and dibassic phosphate brand, ultrasound time and source of water), IR (linear between 1.0 to 2.0 mg/150 mg, precisewith RSD up to 3.12 %, accurate with mean recovery of 99.37 %, selectivewhen vancomycin sample and reference spectra were overlapped, robustwhen variations were performed in strength of compression), HPLC(linear between 40 to 140 µg/mL, precisewith RSD up to 2.35%, accurate with mean recovery of 100,19 %, selective under acid, alkaline, aqueous, oxidative and photolytic degradation, robustwhen variations were performed in wavelength, acid concentration in mobile phase, ethanol brand, mobile phase proportion, ultrasound time and source of wwater) andbioassay turbidimetry (linear between 30 and 50.7 µg/mL, precise with RSD up to 4.42%, accurate ith mean recovery of 100.71 %, selectivewhen vancomycin sample and reference absorbance values were compared, robust when variations were performed in wavelength and temperature of incubation), in accordance with the legislation stipulated limits for each validation parameter. Moreover, these four analytical methods were statistically compared and proved that the HPLC and UV methods are interchangeable (tcalculated 0.049 < ttabulated 2.77), and must always be apllied in association with the microbiological method, because this is an antimicrobial drug. In this way, this work proposes ecologically correct and sustainable methods for pharmaceutical analysis of vancomycin dosage form. (AU)

FAPESP's process: 18/02540-6 - Development and validation of analytical methods for quantification of vancomycin lyophilized powder for injection solution
Grantee:Patricia Aleixa Do Nascimento
Support type: Scholarships in Brazil - Master