Analytical methods of phytochemicals from the Cuphea genus : a review

Cuphea genus (Lythraceae) comprises about 260 species. The dispersion of the genus occurs in two mains geographic centers: North and South America, with Brazil being the most Cuphea species-rich country, with approximately 104 identified species. Still poorly studied, the number of papers about genus has been growing considerably. However, a review of its analytical methods has not been previously performed. Therefore, this review aims to provide studies about different chromatographic methods used for the separation, elucidation, and identification of metabolites present in species of the Cuphea genus. Research in scientific databases like Scopus, PubMed, and Science Direct were managed, and all references were analyzed. This review covers the relevant literature until May 2021, totalizing 22 studies described on 12 species of Cuphea. Most methods were employed for chemical analysis, and just one of them was validated for quantification purposes. Thus, this review provides a brief overview of the different chromatographic methods used in the separation, elucidation, and identification of compounds on different species of the Cuphea genus

Development and validation of a new analytical method based on UV-visible spectroscopy for quantification of ceftaroline fosamil in powder for injection

Quantification of drugs is an essential part for ensuring quality, safety and efficacy of pharmaceutical formulations. For this, validated methods must be used in order to guarantee analytical reliability during monitoring in clinical studies and quality control. In the present study, we aim to develop a reliable, accurate, accessible and rapid UV-VIS spectrophotometry method for quantification of ceftaroline fosamil in powder for intravenous administration. Each analyzed solution was prepared individually and the only reagent used was Milli-Q water, as a solvent, making the method eco-friendly. The absorbances were measured at 242 nm, the peak absorbance found for the drug. The developed method was validated according to ICH and ANVISA guidelines, proving to be specific and demonstrating good linearity in the concentration range of 5 μg.mL-1 to 15 μg.mL-1, with determination (r2) and correlation coefficients (r) equal to 0.9999. The limits of detection and quantification found were acceptable (0.51 μg.mL-1 and 1.55 μg.mL-1, respectively).  The method exhibited excellent intermediate precision and repeatability, with relative standard deviation values of 0.87% and 0.98%, respectively. Furthermore, the method’s accuracy was confirmed, showing a mean recovery of 100 ± 2.67%. Additionally, the robustness was assayed and confirmed using Plackett-Burmann design. In conclusion, the method can easily be applied for routine quality control analysis

Analytical methods of phytochemicals from the Cuphea genus - A review

Cuphea genus (Lythraceae) comprises about 260 species. The dispersion of the genus occurs in two mains geographic centers: North and South America, with Brazil being the most Cuphea species-rich country, with approximately 104 identified species. Still poorly studied, the number of papers about genus has been growing considerably. However, a review of its analytical methods has not been previously performed. Therefore, this review aims to provide studies about different chromatographic methods used for the separation, elucidation, and identification of metabolites present in species of the Cuphea genus. Research in scientific databases like Scopus, PubMed, and Science Direct were managed, and all references were analyzed. This review covers the relevant literature until May 2021, totalizing 22 studies described on 12 species of Cuphea. Most methods were employed for chemical analysis, and just one of them was validated for quantification purposes. Thus, this review provides a brief overview of the different chromatographic methods used in the separation, elucidation, and identification of compounds on different species of the Cuphea genus

Development and validation of a new analytical method based on UV-visible spectroscopy for quantification of ceftaroline fosamil in powder for injection

Quantification of drugs is an essential part for ensuring quality, safety and efficacy of pharmaceutical formulations. For this, validated methods must be used in order to guarantee analytical reliability during monitoring in clinical studies and quality control. In the present study, we aim to develop a reliable, accurate, accessible and rapid UV-VIS spectrophotometry method for quantification of ceftaroline fosamil in powder for intravenous administration. Each analyzed solution was prepared individually and the only reagent used was Milli-Q water, as a solvent, making the method eco-friendly. The absorbances were measured at 242 nm, the peak absorbance found for the drug. The developed method was validated according to ICH and ANVISA guidelines, proving to be specific and demonstrating good linearity in the concentration range of 5 μg.mL-1 to 15 μg.mL-1, with determination (r2) and correlation coefficients (r) equal to 0.9999. The limits of detection and quantification found were acceptable (0.51 μg.mL-1 and 1.55 μg.mL-1, respectively). The method exhibited excellent intermediate precision and repeatability, with relative standard deviation values of 0.87% and 0.98%, respectively. Furthermore, the method’s accuracy was confirmed, showing a mean recovery of 100 ± 2.67%. Additionally, the robustness was assayed and confirmed using Plackett-Burmann design. In conclusion, the method can easily be applied for routine quality control analysis

Microbiological assay for quantitative determination of Imipenem in powder for injection

This work describes the development and validation of a microbiological method using the cylinder-plate assay for quantitative determination of imipenem in powder for injection. The aim was to obtain a low-cost and suitable methodology that can be alternative to physicochemical techniques already described, contributing for the quality control of this antibiotic. Firstly, the analytical conditions were optimized, testing the microorganism, inoculum concentration and best range of sample and standard concentrations, in a way that provides the adequate measurement of the inhibition halos. Staphylococcus epidermidis ATCC 12228 was selected as test microorganism, as well as 2.0 % of inoculum concentration. The validation protocol followed the official guidelines, and the parameters evaluated were linearity, precision (intermediate precision and repeatability) and accuracy. All standard curves ranging 0.5-2.0 μg/mL showed r values higher than 0.999, and ANOVA confirmed that were no deviation from linearity (p-value > 0.05). The method also proved to be precise with RSD (relative standard deviation) values ranging 0.28-0.64 for repeatability and 2.49 for intermediate precision. It was performed three days of experiments, being three assays of eight plates a day. The drug mean content was 101.05%. Accuracy was assessed by recovery test, with standard recovery percentage of 101.70-107.90% (mean recovery = 104.86%), which was considered satisfactory. Therefore, the proposed microbiological method was considered validated and suitable for application in quantitative determination of this drug, being useful for quality control routine

pH effect on stability and kinetics degradation of nitazoxanide in solution

Stability studies correspond to a set of tests designed to assess changes in the quality of a given drug over time and under the influence of a number of factors. Among these factors, pH plays an important role, due to the catalytic effect that hydronium and hydroxide ions can play in several reactions. In the present study, the degradation kinetics of nitazoxanide was evaluated over a wide pH range, and the main degradation product generated was identified by LC-MS/MS. Nitazoxanide showed first-order degradation kinetics in the pH range of 0.01 to 10.0 showing greater stability between pH 1.0 and 4.0. The degradation rate constant calculated for these pH was 0.0885 x 10-2 min-1 and 0.0689 x 10-2 min-1, respectively. The highest degradation rate constant value was observed at pH 10.0 (0.7418 x 10-2 min-1) followed by pH 0.01 (0.5882 x 10-2 min-1). A major degradation product (DP-1) was observed in all conditions tested. Through LC-MS/MS analysis, DP-1 was identified as a product of nitazoxanide deacetylation. The effect of pH on the stability of nitazoxanide and the kinetic data obtained contribute to a better understanding of the intrinsic stability characteristics of nitazoxanide