A Clean, Sustainable and Stability-Indicating Method for the Quantification of Ceftriaxone Sodium in Pharmaceutical Product by HPLC.

Ceftriaxone sodium is a widely used antimicrobial, which is only available as a lyophilized powder. The presence of methods for evaluating the quality of this product is very important and helps to ensure its effectiveness, in addition to contributing to the fight against bacterial resistance. Therefore, a clean and sustainable high-performance liquid chromatography (HPLC) method has been developed for evaluating ceftriaxone stability in pharmaceutical product. A Zorbax SB C18 (150 × 4.6 mm, 5 µm) column was maintained at 25°C; the mobile phase consisted of purified water acidified with 0.2% orthophosphoric acid and ethanol (87: 13, v/v) at a flow rate of 0.9 mL min-1. The detection wavelength was set at 260 nm. The method was linear over a concentration range of 20-120 µg mL-1, precise with relative standard deviations <2%, robust in the event of minor changes to the original method conditions, accurate with recovery between 98% and 102% and specific to degradation products. The retention time for ceftriaxone sodium was ~4.6 minutes. This work shows an ecologically correct option by HPLC method for the evaluation of ceftriaxone sodium in pharmaceutical product, as well as its stability, which addresses the requirements of the current green and sustainable analytical chemistry.

Turbidimetric Method: A Multi-Advantageous Option for Assessing the Potency of Ceftriaxone Sodium in Powder for Injection.

BACKGROUND: Ceftriaxone sodium, an antimicrobial used in parenteral form, does not have a microbiological method by turbidimetry described in the literature. For drugs from antimicrobial class, the existence of a microbiological method for assessing their potency is essential. Not only are the results from the physical-chemical methods enough, but microbiological analyzes are also necessary. OBJECTIVE AND METHODS: Thus, this paper reports the development and validation of an efficient, accurate, reproducible, fast, and low-cost microbiological assay by turbidimetry to quantify ceftriaxone sodium in powder for injection. Water was used as the diluent to prepare the ceftriaxone solutions. BHI broth as used as culture media for the growth of the S. aureus ATCC 6538 at 9%. RESULTS: The method was linear in the range of 100-196 µg/mL, selective against the sample adjuvants and the forced degradation test, precise (intraday RSD 4.53%, interday RSD 3.85% and between analysts tcalculated 0.14 < 2.23 tcritical), accurate with recovery of 100.33% and robust against minor changes in the volume of culture medium used, wavelength, incubation time, and inoculum concentration. CONCLUSIONS AND HIGHLIGHTS: The turbidimetric method developed in this paper is a convenient and valuable alternative to the routine quality control of ceftriaxone sodium in powder for injection, since it allows a reliable quantification and can be used to complement the physical-chemical analysis.

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

Ceftriaxone sodium is a third-generation semi-synthetic antibiotic belonging to the class of cephalosporins. Is administered only by parenteral route and has the ability to cross the blood-brain barrier. It has bactericidal action; its main activity is related to the Gram-negative bacteria, being also able to act against Gram-negative bacilli resistant to the first- and second-generation cephalosporins. The present study presents a survey of the characteristics, properties and analytical methods used for the determination of ceftriaxone sodium, for the gathering of data searches were carried out in scientific articles in the world literature, as well as in the official compendia. It is necessary to create awareness about the importance of developing effective and reliable analytical methods for quality control and consequently for conducting pharmacokinetic, bioavailability, bioequivalence studies as well as for the therapeutic monitoring of this drug. Most of the methods found use high-performance liquid chromatography, but also methods that use absorption spectroscopy ultraviolet, infrared spectroscopy, spectrofluorimetry and microbiological methods have been presented. A discussion was presented highlighting the need to develop new ecological methods using less toxic solvents, rapid analysis and miniaturization of the samples.

Metformin: A Review of Characteristics, Properties, Analytical Methods and Impact in the Green Chemistry.

Diabetes mellitus (DM) is considered a public health problem. The initial treatment consists of improving the lifestyle and making changes in the diet. When these changes are not enough, the use of medication becomes necessary. The metformin aims to reduce the hepatic production of glucose and is the preferred treatment for type 2. The objective is to survey the characteristics and properties of metformin, as well as hold a discussion on the existing analytical methods to green chemistry and their impacts for both the operator and the environment. For the survey, data searches were conducted by scientific papers in the literature as well as in official compendium. The characteristics and properties are shown, also, methods using liquid chromatography techniques, titration, absorption spectrophotometry in the ultraviolet and the infrared region. Most of the methods presented are not green chemistry oriented. It is necessary the awareness of everyone involved in the optimization of the methods applied through the implementation of green chemistry to determine the metformin.