Ertapenem sodium is a polar and ionizable compound; therefore, it has little retention on traditional C18 columns in reverse-phase high-performance liquid chromatography, even using a highly-aqueous mobile phase that can result in dewetting in the stationary phase. Thus, the most coherent process for ERTM is to develop a method for Hydrophilic Interaction Chromatography. However, for the traditional methods in HILIC, the use of a highly organic mobile phase is necessary; usually an amount exceeding 80% acetonitrile is necessary. On the other hand, the RP-HPLC mode is considered for the analysis technique, which is more often used for quantification of substances, and new columns are often introduced to analyze different groups of compounds. Two new analytical methods have been developed for routine analysis. The proposed chromatographic method was adequate and advantageous by presenting simplicity, linearity, precision, accuracy, robustness, detection limits, and satisfactory quantification. Analytical methods are constantly undergoing changes and improvements. Researchers worldwide are rapidly adopting Green Chemistry. The development of new pharmaceutical methods based in Green chemistry has been encouraged by universities and the pharmaceutical industry. Issues related to green chemistry are in evidence and they have been featured in international journals of high impact. The methods described here have economic advantages and they feature an eco-friendly focus, which is discussed in this work. This work was developed with an environmental conscience, always looking to minimize the possible generated organic waste. Therefore, discussion on this aspect is included.
In this paper a new microbiological method for quantifying and evaluating the potency of cefazolin sodium is presented in order to produce safe medicines for the population.
A reversed-phase high performance liquid chromatography method was validated for the determination of cefazolin sodium in lyophilized powder for solution for injection to be applied for quality control in pharmaceutical industry. The liquid chromatography method was conducted on a Zorbax Eclipse Plus C 18 column (250 x 4.6 mm, 5 μm), maintained at room temperature. The mobile phase consisted of purified water: acetonitrile (60: 40 v/v), adjusted to pH 8 with triethylamine. The flow rate was of 0.5 mL min -1 and effluents were monitored at 270 nm. The retention time for cefazolin sodium was 3.6 min. The method proved to be linear (r 2 =0.9999) over the concentration range of 30-80 µg mL -1 . The selectivity of the method was proven through degradation studies. The method demonstrated satisfactory results for precision, accuracy, limits of detection and quantitation. The robustness of this method was evaluated using the Plackett-Burman fractional factorial experimental design with a matrix of 15 experiments and the statistical treatment proposed by Youden and Steiner. Finally, the proposed method could be also an advantageous option for the analysis of cefazolin sodium, contributing to improve the quality control and to assure the therapeutic efficacy.Uniterms: Cefazolin sodium/determination. High performance liquid chromatography/reverse-phase/ quantitative analysis. Pharmaceutical industry/quality control. Cefalosporine/quality control. Medicines/ quality control.Um método cromatográfico em fase reversa foi validado para a determinação de cefazolina sódica em pó liofilizado, a ser aplicado no controle de qualidade em indústrias farmacêuticas. O método por cromatografia líquida foi conduzido em coluna Zorbax Eclipse Plus C18 (250 × 4,6 mm, 5 µm) mantida à temperatura ambiente. A fase móvel consistiu de água purificada: acetonitrila (60 : 40 v/v), com o pH ajustado para 8 com trietilamina. A vazão usada foi de 0,5 mL min -1 e os analitos de interesse foram monitorizados a 270 nm. O tempo de retenção da cefazolina sódica foi de 3,6 min. As áreas dos picos de cefazolina sódica foram lineares na faixa de concentração de 30-80 µg mL -1 (r 2 = 0,9999). A seletividade do método foi demonstrada através de estudos de degradação. O método demonstrou resultados satisfatórios para precisão, exatidão, limites de detecção e de quantificação. A robustez do método foi avaliada utilizando o esquema fatorial de Plackett-Burman com uma matriz de 15 experimentos simultâneos, e analisados por tratamento estatístico proposto por Youden e Steiner. Finalmente, o método proposto pode ser também uma opção de êxito para a análise de cefazolina sódica, contribuindo para o controle de qualidade e para garantir a eficácia terapêutica.Unitermos: Cefazolina sódica/determinação. Cromatografia líquida de alta eficiência/fase reversa/ análise quantitativa. Indústria farmacêutica/controle de qualidade. Cefalosporina/controle de qualidade. Medicamentos/controle de qualidade.
An innovative method is validated for the analysis of ertapenem sodium by capillary electrophoresis using potassium phosphate buffer 10 mM pH 7 and 15 kV voltage, in the concentration range of 70 to 120 μg mL−1. Ertapenem had a migration time of 3.15 minutes and the linearity curve was y = 2281.7 x - 24495 with a R2 = 0.9994. Thus, we propose a routine analysis method that meets the principles of green analytical chemistry for the routine analysis of ertapenem sodium by capillary electrophoresis.
RESUMO:A semiologia farmacêutica pode ser entendida como a identificação de sinais e sintomas, principalmente aqueles relacionados aos transtornos/distúrbios menores relatados pelo paciente. Essa prática profissional não deve ser confundida com diagnóstico, que é uma atividade realizada pelo médico, mas como uma nova ferramenta na dispensação ativa de medicamentos de venda livre. Este estudo visa identificar o desenvolvimento dessa prática profissional e discutir os desafios necessários à sua implementação. PALAVRAS-CHAVE: Semiologia farmacêutica; Doenças menores; Prescrição farmacêutica; Automedicação orientada; Medicamentos isentos de prescrição.ABSTRACT: Pharmaceutical semiology can be comprehended as the identification of signs and symptoms, especially those related to minor disturbances/disorders reported by the patients. This practice should not be confused with diagnosis, which is an activity performed by the doctor, but as a new tool in the active dispensing of prescription drugs. This study aims to identify the development of this practice and discuss the challenges required for its implementation. KEYWORDS:Semiology pharmaceutical; Minor illnesses; Prescription pharmaceuticals; Oriented self-medication; Over the counter medicine. RESUMÉN:La semiología farmacéutica puede ser entendida como la identificación de los signos y síntomas, en especial los relacionados con los trastornos / alteraciones menores reportados por el paciente. Esta práctica profesional no debe ser confundido con el diagnóstico, que es una actividad realizada por el médico, sino como una nueva herramienta de dispensación en los medicamentos de venta libre. Este estudio tiene como objetivo identificar el desarrollo de esta práctica profesional y discutir los retos necesarios para su aplicación. PALABRAS CLAVE: Semiología farmacêuticos; Enfermedades menores; Medicamentos con receta; Orientada a la automedicación; Medicamentos de venta libre.
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