Application of the Principles of Green Chemistry for the Development of a New and Sensitive Method for Analysis of Ertapenem Sodium by Capillary Electrophoresis.

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.

A Critical Review of Analytical Methods for Determination of Ertapenem Sodium.

Antimicrobials have unquestionable importance in the control of many diseases; however the constant concern with evolution of resistant microorganisms is increasing. Ertapenem sodium is a ß-lactam antibiotic of the carbapenem class that has a broader activity spectrum than most other ß-lactam antimicrobials and is more resistant to the enzyme ß-lactamase, which is the main mechanism of resistance of many bacteria. The progress of microbial resistance to existing antibiotics is alarming. Thus we need to preserve antimicrobials that still have activity against these pathogens. In this context, quality control has a key role to ensure the correct dosage, by contributing preventively to minimize the development of resistant microorganisms. Study of the physico-chemical characteristics of the drug and quantification of the content of the active substance are of fundamental importance for the pharmaceutical industry to ensure the quality of the product sold. This work presents the results of a literature survey of existing methods for ertapenem sodium quantification. Ertapenem sodium can be analyzed by many types of assays; however, HPLC is the most used method. This review will examine the published analytical methods reported for determination of ertapenem sodium in biological fluids and formulations.

Validation of analytical methodology for quantification of cefazolin sodium pharmaceutical dosage form by high performance liquid chromatography to be applied for quality control in pharmaceutical industry

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 C18 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 (r2=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.

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 (r2 = 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.